Company · US
Stryker Neurovascular
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (4 in 12 months)
109recalls (1 in 12 months)
101recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HCG | Device, Neurovascular Embolization | 48 |
| DQY | Catheter, Percutaneous | 36 |
| NRY | Catheter, Thrombus Retriever | 13 |
| QJP | Catheter, Percutaneous, Neurovasculature | 12 |
| DQX | Wire, Guide, Catheter | 11 |
| MJN | Catheter, Intravascular Occluding, Temporary | 9 |
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | 6 |
| NJE | Intracranial Neurovascular Stent | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 2 |
| KRD | Device, Vascular, For Promoting Embolization | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K261649 | Excelsior Reach Microcatheter Stryker Neurovascular | QJP |
| Jul 1, 2026 | K261889 | Trevo Trak 21 Microcatheter Stryker Neurovascular | QJP |
| Feb 11, 2026 | K253032 | AXS Lift Intracranial Base Catheter Stryker Neurovascular | QJP |
| Dec 11, 2025 | K252694 | Target Detachable Coil Stryker Neurovascular | HCG |
| Oct 17, 2025 | K251832 | InZone IST Detachment System; IZDS Connecting Cable Stryker Neurovascular | HCG |
| Mar 21, 2025 | K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior X Stryker Neurovascular | QJP |
| Feb 18, 2025 | K243593 | AXS Lift Intracranial Base Catheter Stryker Neurovascular | QJP |
| Dec 19, 2024 | K241768 | Broadway 8 Catheter Stryker Neurovascular | QJP |
| Dec 19, 2024 | K241637 | Echo Intracranial Base Catheter Stryker Neurovascular | QJP |
| Mar 29, 2023 | K223305 | Trevo NXT ProVue Retriever Stryker Neurovascular | POL |
| Dec 14, 2022 | K222533 | Target Tetra Detachable Coils Stryker Neurovascular | HCG |
| Nov 26, 2021 | K211594 | Trevo Trak 21 Microcatheter Stryker Neurovascular | QJP |
| Nov 16, 2021 | K212455 | InZone Detachment System Stryker Neurovascular | HCG |
| Aug 27, 2021 | K210502 | Trevo NXT ProVue Retriever Stryker Neurovascular | POL |
| Aug 27, 2021 | K202752 | AXS Vecta 46 Intermediate Catheter Stryker Neurovascular | QJP |
| Dec 29, 2020 | K203219 | Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever Stryker Neurovascular | POL |
| Sep 25, 2020 | K202522 | Synchro SELECT Guidewire Stryker Neurovascular | MOF |
| Feb 27, 2020 | K200206 | AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter Stryker Neurovascular | QJP |
| Dec 15, 2019 | K190833 | AXS Vecta Aspiration Catheter Stryker Neurovascular | DQY |
| Nov 29, 2019 | K193034 | AXS Infinity LS Plus Long Sheath Stryker Neurovascular | DQY |
| Jul 30, 2019 | K191768 | AXS Vecta Aspiration System Stryker Neurovascular | NRY |
| Apr 24, 2019 | K190212 | AXS Vecta Aspiration System Stryker Neurovascular | NRY |
| Jul 28, 2017 | K163259 | AXS Offset Delivery Assist Catheter Stryker Neurovascular | DQY |
| Jun 22, 2016 | K161429 | Target Detachable Coils Stryker Neurovascular | HCG |
| May 19, 2016 | K153658 | Target Detachable Coils Stryker Neurovascular | HCG |
| Feb 19, 2016 | K160096 | InZone Detachment System Stryker Neurovascular | HCG |
| Nov 14, 2014 | K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior X Stryker Neurovascular | DQY |
| Nov 15, 2013 | K132542 | TRANSGATE GUIDE CATHETER Stryker Neurovascular | DQY |
| Jan 11, 2013 | K122576 | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT Stryker Neurovascular | MJN |
| Nov 30, 2012 | K123377 | TARGET DETACHABLE COIL Stryker Neurovascular | HCG |
| Apr 20, 2012 | K113778 | EXCELSIOR XT-27 MICROCATHETER Stryker Neurovascular | DQY |
| Apr 17, 2012 | K120850 | TARGET DETACHABLE COIL Stryker Neurovascular | HCG |
| Dec 13, 2011 | K113412 | TARGET DETACHABLE COIL Stryker Neurovascular | HCG |
| Sep 15, 2011 | K112385 | TRAGET DETACHABLE COIL Stryker Neurovascular | HCG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | Stryker Neurovascular INZONE DETACHMENT SYSTEM, REF: M00345100950 Open, Classified |
HCG | K212455 |
| Oct 7, 2024 | Stryker Neurovascular The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a h Open, Classified |
QJP | K211594 |
| May 31, 2024 | Stryker Neurovascular The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewire Open, Classified |
DQX | K053268 |
| May 31, 2024 | Stryker Neurovascular The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable
tip and are available in straight and pre-shaped versions. The outside diameters of the
guidewires are 0.014in. The guid Open, Classified |
MOF | K202522 |
| May 31, 2024 | Stryker Neurovascular The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.0 Open, Classified |
DQX | K032146 |
| May 28, 2024 | Stryker Neurovascular Synchro .014"guide wire, 35 cm tip, Catalog: M00313010
Synchro .014 guide wire, 300 cm length, Catalog: M00313310
SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310
SYNCHRO .010 WIRE SOFT STRAI Open, Classified |
DQX | K002907 K023700 |
| May 28, 2024 | Stryker Neurovascular DAC 044 115cm, Catalog: 90760 Open, Classified |
DQY | K133177 |
| May 28, 2024 | Stryker Neurovascular FlowGate2 8F x 85cm, Catalog: 90485
FlowGate2 8F x 95cm, Catalog: 90495 Open, Classified |
DQY | K153729 |
| May 28, 2024 | Stryker Neurovascular Trevo Trak 21 Microcatheter, Catalog: 90338 Open, Classified |
QJP | K211594 |
| May 28, 2024 | Stryker Neurovascular Trevo NXT ProVue 3 x 32, US, Catalog: 90312
Kits:
TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412
TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413
TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 Open, Classified |
POL | K223305 |
| May 28, 2024 | Stryker Neurovascular Trevo Pro 14 Microcatheter, Catalog: 90231;
Trevo Pro 18 Microcatheter, Catalog: 90238 Open, Classified |
DQO | K113260 K131437 |
| May 28, 2024 | Stryker Neurovascular Trevo ProVue, Catalog: 90184 Open, Classified |
NRY | K133464 |
| May 28, 2024 | Stryker Neurovascular Trevo XP ProVue Retriever 4 x 20, Catalog: 90182
Trevo XP ProVue Retriever 3 x 20, Catalog: 90183
Trevo XP ProVue Retriever 4 x 30, Catalog: 90185
Trevo XP ProVue Retriever 6 x 25, Catalog: 90186
Kit Open, Classified |
POL | K173352 |
| May 1, 2024 | Stryker Neurovascular The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophil Open, Classified |
DQY | K133177 |
| Jun 3, 2022 | Stryker Neurovascular Trevo Trak 21 Microcatheter, REF: 90338.
TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412;
TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413;
TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414;
TREVO NXT 6X37+TR Open, Classified |
DQO | K192122 |
| Oct 21, 2020 | Stryker Neurovascular Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK6 Terminated |
POL | K190779 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: product is intended for general intravascular use, i Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neur Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, i Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including ne Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, incl Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurov Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, inc Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neuro Terminated |
DQX | K190843 |
| Jun 2, 2019 | Stryker Neurovascular Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876):
a) REF: INC-11196-70, 70cm,
b) REF: INC-11196-80, 80cm,
c) REF: INC-11196-9 Terminated |
DQY | K172468 |
| Apr 10, 2019 | Stryker Neurovascular Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, Terminated |
NRY | K181354 |
| Apr 10, 2019 | Stryker Neurovascular Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, Terminated |
NRY | K172167 |
| Nov 13, 2018 | Stryker Neurovascular Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771 Terminated |
DQY | K010954 K112404 |
| Jul 28, 2018 | Stryker Neurovascular FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) Terminated |
DQY | K153729 |
| Jun 5, 2018 | Stryker Neurovascular Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090,
M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450 Terminated |
NJE | None listed |
| May 2, 2018 | Stryker Neurovascular AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system Terminated |
DQY | K152876 |
| Dec 5, 2017 | Stryker Neurovascular Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068
Stroke intervention kit Terminated |
NRY | K113260 K113778 +3 |
| Dec 5, 2017 | Stryker Neurovascular Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 Terminated |
NRY | K113260 K113778 +3 |
| Dec 5, 2017 | Stryker Neurovascular Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M Terminated |
NRY | K113260 K113778 +3 |
| Nov 28, 2017 | Stryker Neurovascular Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter Terminated |
NRY | K113260 K132641 |
| Jun 26, 2017 | Stryker Neurovascular Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001
ST 150 Terminated |
NRY | None listed |
| Jun 26, 2017 | Stryker Neurovascular Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30,
Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001 Terminated |
NRY | None listed |
| Jun 26, 2017 | Stryker Neurovascular Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20,
Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001 Terminated |
NRY | None listed |
| Jun 26, 2017 | Stryker Neurovascular Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001 Terminated |
NRY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER 40XF 5F 90CM, Model number:M003100620 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices int Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devi Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER STRAIGHT XF 5F 90CM, Model number: .
M003100640.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional dev Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER MPXF 5F 90CM, Model number: M003100630.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices int Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/ST XF/6FR/100 cm, Model number:M003101500 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional de Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40XF/8FR/90CM, Model number: H965100440 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional dev Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER MPXF 5F 100CM, Model number: M003101630.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices in Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40DEG XF/6FR/90CM, Model number: H965100420.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional device Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/ST XF/8FR/90CM, Model number: H965100520.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | K010853 K980453 |
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