METRONIC MODEL F7700 HEART VALVE SIZERS
FDA 510(k) clearance K852612 · decided 1985-09-23
Clearance details
- K-number
- K852612
- Device name
- METRONIC MODEL F7700 HEART VALVE SIZERS
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 1985-06-19
- Decision date
- 1985-09-23
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- DTI
- Device class
- 1
- Regulation number
- 870.3945
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (K952184) | Carbomedics, Inc. | 1995-11-29 |
| VALVE SIZER (K934951) | Carbomedics, Inc. | 1993-12-10 |
| EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (K881279) | Baxter Healthcare Corp | 1988-05-18 |
| DUROMEDICS CARDIAC VALVE SIZER SET (K853313) | Hemex Scientific, Inc. | 1985-11-01 |
| MITRAL VALVE ORIFICE SIZER (K820887) | Celtech | 1982-07-08 |
| HANCOCK * OBTURATORS (K801885) | Hancock Laboratories, Inc. | 1980-09-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
| Endurant II/IIs Stent Graft System (P100021/S131) | Medtronic Vascular | 2025-10-23 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129) | Medtronic Vascular | 2025-09-15 |
| Resolute Onyx (P160043/S088) | Medtronic Vascular | 2025-06-26 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
| Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069) | Medtronic Vascular | 2025-05-08 |