Panels › Cardiovascular › Product code DQY · Class 2
Catheter, Percutaneous
Regulation 870.1250
13510(k)s in 12 months (896 all time)
2recalls in 12 months (620 all time)
583recalls that name a 510(k)
Top companies in DQY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 31 | 198 |
| Medtronic | 15 | 148 |
| Boston Scientific | 30 | 59 |
| ARROW INTERNATIONAL, LLC | 0 | 41 |
| Stryker Neurovascular | 6 | 30 |
| Cook Incorporated | 22 | 13 |
| Vascular Solutions, Inc. | 27 | 6 |
| Codman & Shurtleff, Inc. | 8 | 24 |
| Bard Peripheral Vascular, Inc. | 5 | 23 |
| Cordis Corp. | 22 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | MICROVENTION INC. BOBBY Balloon Guide Catheter
REF:
BOB-895-CN
BOB-895-EMEA
BOB-895-EMEA-AL
BOB-895-US
MV-BGA01095
For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood Open, Classified |
DQY | K193607 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6
RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP
ACCESS TRAY/ASK-04001-MS
RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1
VESSEL CATH KIT: 20GA X 5 Open, Classified |
DQY | K021120 K171146 +3 |
| Oct 24, 2025 | BALT USA, LLC Brand Name: MEGA Ballast Distal Access Platform
Product Name: Mega Ballast
Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110
Software Version: N/A
Product Description: The Meg Open, Classified |
DQY | K242376 |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems. Open, Classified |
DQY | K240018 |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems. Open, Classified |
DQY | K212228 |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of
WATCHMAN FLX LAAC Devices with Delivery Systems. Open, Classified |
DQY | K212228 |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Syst Open, Classified |
DQY | None listed |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Syst Open, Classified |
DQY | K180864 |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Syst Open, Classified |
DQY | K180864 |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems. Open, Classified |
DQY | None listed |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems. Open, Classified |
DQY | K212228 |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Sys Open, Classified |
DQY | K180864 |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Sys Open, Classified |
DQY | K180864 |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Sys Open, Classified |
DQY | K180864 |
| Apr 21, 2025 | Abbott Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 Open, Classified |
DQY | K162228 |
| Apr 21, 2025 | Abbott Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 Open, Classified |
DQY | K131063 |
| Mar 13, 2025 | Cordis US Corp Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F.
Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or Open, Classified |
DQY | K021593 |
| Jan 17, 2025 | MICROVENTION INC. Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846 Open, Classified |
DQY | K101542 |
| 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 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 |
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients. Open, Classified |
DQY | None listed |
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature. Open, Classified |
DQY | K190431 |
| Jan 2, 2024 | Merit Medical Systems, Inc. Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY Open, Classified |
DQY | K173548 |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter Open, Classified |
DQY | None listed |
| Oct 3, 2023 | Boston Scientific Corporation Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter Open, Classified |
DQY | None listed |
| Jul 11, 2023 | Abbott Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac). Open, Classified |
DQY | K220340 |
| Mar 13, 2023 | Scientia Vascular, Inc. Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090 Open, Classified |
DQY | K210601 |
| Aug 25, 2022 | Boston Scientific Corporation Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 Open, Classified |
DQY | K010853 K980453 |
| May 25, 2022 | Cook Incorporated Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838 Completed |
DQY | None listed |
| Apr 20, 2022 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to Open, Classified |
DQY | K183493 |
| Nov 9, 2021 | Abbott Amplatzer Steerable Delivery Sheath Terminated |
DQY | K212026 |
| Sep 9, 2021 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) C315-HIS Delivery Catheter Open, Classified |
DQY | K101885 |
| Jul 23, 2021 | Mivi Neuroscience Inc MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only.
Device is use Terminated |
DQY | K151396 |
| Jul 23, 2021 | Mivi Neuroscience Inc MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile.
Device i Terminated |
DQY | K151396 |
| Apr 21, 2021 | MICROVENTION INC. VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. Terminated |
DQY | K192135 |
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