Panels › Cardiovascular › Product code DRA · Class 2
Catheter, Steerable
Regulation 870.1280
1510(k)s in 12 months (42 all time)
4recalls in 12 months (10 all time)
9recalls that name a 510(k)
Top companies in DRA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01 Open, Classified |
DRA | K233248 |
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01 Open, Classified |
DRA | K233248 |
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062 Open, Classified |
DRA | K233248 |
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01 Open, Classified |
DRA | None listed |
| Mar 26, 2024 | Boston Scientific Corporation Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 Open, Classified |
DRA | K223824 |
| Aug 24, 2021 | Medtronic Perfusion Systems DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only Open, Classified |
DRA | K834352 |
| Aug 24, 2021 | Medtronic Perfusion Systems DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only Open, Classified |
DRA | K834352 |
| Sep 26, 2012 | Greatbatch Medical Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Med Terminated |
DRA | K112541 |
| Sep 12, 2011 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of cathe Terminated |
DRA | K102176 |
| Sep 11, 2008 | Hansen Medical Inc Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and cont Terminated |
DRA | K052480 |
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