Panels › Cardiovascular › Product code NTE · Class 2
Temporary Carotid Catheter For Embolic Capture
Regulation 870.1250
0510(k)s in 12 months (36 all time)
2recalls in 12 months (30 all time)
30recalls that name a 510(k)
Top companies in NTE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2026 | Boston Scientific Corporation Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter Open, Classified |
NTE | K230402 |
| Aug 20, 2026 | Boston Scientific Corporation Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter Open, Classified |
NTE | K153485 |
| Nov 17, 2023 | Medtronic Inc Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5 Open, Classified |
NTE | K092177 |
| Nov 17, 2023 | Medtronic Inc Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6 Open, Classified |
NTE | K092177 |
| Nov 17, 2023 | Medtronic Inc Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 Open, Classified |
NTE | K092177 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC Open, Classified |
NTE | K220654 |
| Dec 21, 2021 | Cardiovascular Systems Inc WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6 Terminated |
NTE | K210282 |
| Mar 27, 2014 | Medtronic Vascular, Inc. FIBERNET Embolic Protection System:
Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter:
0.014 in (0.36mm)
Rx only, Sterile;
Manufactured in:
Invatec S.P.A., Italy;
Manufacturer:
Medtr Terminated |
NTE | K082349 |
| Mar 27, 2014 | Medtronic Vascular, Inc. FIBERNET Embolic Protection System:
Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter:
0.014 in (0.36mm)
Rx only, Sterile;
Manufactured in:
Invatec S.P.A., Italy;
Manufacturer:
Medtr Terminated |
NTE | K082348 |
| Mar 27, 2014 | Medtronic Vascular, Inc. FIBERNET Embolic Protection System:
Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm)
Rx only, Sterile;
Manufactured in:
Invatec S.P.A., Italy;
Manufacturer:
Me Terminated |
NTE | K082348 |
| Jan 31, 2013 | Abbott Vascular Brand Name: RX Accunet Embolic Protection System
Common Name: RX Accunet EPS.
Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55.
The RX Accu Terminated |
NTE | K081549 |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, MT OUS PV, Material H749201053000, Model # 20105-300, Sterilized with irradiation, Made in USA: 2011 Stierlin Terminated |
NTE | K063313 |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, MT OUS PV, Material H749201051900, Catalog # 20105-190, Sterilized with irradiation, Made in USA: 2011 Stierl Terminated |
NTE | K063313 |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, OUS CV, Material H749201004000, Catalog # 20100-400, Sterilized with irradiation, Made in USA: 2011 Stierlin Terminated |
NTE | K063313 |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, OUS CV, Material H749201003990, Catalog # 20100-399, Sterilized with irradiation, Made in USA: 2011 Stierlin Terminated |
NTE | K063313 |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, US, Material H749201003000, Catalog # 20100-300, Sterilized with irradiation, Made in USA: 2011 Stierlin Cour Terminated |
NTE | K063313 |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, US, Material H749201001900, Catalog # 20100-190, Sterilized with irradiation, Made in USA: 2011 Stierlin Co Terminated |
NTE | K063313 |
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