FlexCath Select Steerable Sheath (10 French)
FDA 510(k) clearance K142684 · decided 2014-11-06
Clearance details
- K-number
- K142684
- Device name
- FlexCath Select Steerable Sheath (10 French)
- Applicant
- Medtronic Cryocath, LP
- Decision
- Substantially Equivalent
- Date received
- 2014-09-19
- Decision date
- 2014-11-06
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sh recall (Z-1276-2015) | Medtronic Inc. Cardiac Rhythm Disease Management | 2015-03-17 |
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 |