REPROCESSED FEMORAL COMPRESSION DEVICE
FDA 510(k) clearance K120204 · decided 2012-04-03
Clearance details
- K-number
- K120204
- Device name
- REPROCESSED FEMORAL COMPRESSION DEVICE
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-23
- Decision date
- 2012-04-03
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- NMF
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, 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 |
|---|---|---|
| REPROCESSED FEMORAL COMPRESSION DEVICE (K012574) | Sterilmed, Inc. | 2002-07-18 |
| VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE (K011832) | Vanguard Medical Concepts, Inc. | 2001-12-21 |
Recalls involving this device
No recalls on record reference this clearance.