FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
FDA 510(k) clearance K102176 · decided 2010-09-01
Clearance details
- K-number
- K102176
- Device name
- FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
- Applicant
- Medtronic Cryocath, LP
- Decision
- Substantially Equivalent
- Date received
- 2010-08-03
- Decision date
- 2010-09-01
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DRA
- Device class
- 2
- Regulation number
- 870.1280
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kirkland, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a perc recall (Z-3186-2011) | Medtronic Inc. Cardiac Rhythm Disease Management | 2011-09-12 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S112) | Medtronic Cryocath, LP | 2025-03-27 |
| ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S150) | Medtronic Cryocath, LP | 2025-03-27 |
| ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S151) | Medtronic Cryocath, LP | 2025-03-18 |
| Nitron CryoConsole, Nitron Foot Switch (P020045/S110) | Medtronic Cryocath, LP | 2024-11-25 |
| Coaxial Umbilical Cable (P020045/S111) | Medtronic Cryocath, LP | 2024-11-13 |
| Manual Retraction Kit (P100010/S149) | Medtronic Cryocath, LP | 2024-11-13 |
| Arctic Front Advance Pro (P100010/S148) | Medtronic Cryocath, LP | 2024-07-03 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S147) | Medtronic Cryocath, LP | 2024-06-07 |