VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
FDA 510(k) clearance K011832 · decided 2001-12-21
Clearance details
- K-number
- K011832
- Device name
- VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
- Applicant
- Vanguard Medical Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-12
- Decision date
- 2001-12-21
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- NMF
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lakeland, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vanguard Medical Concepts
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K120204) | Sterilmed, Inc. | 2012-04-03 |
| REPROCESSED FEMORAL COMPRESSION DEVICE (K012574) | Sterilmed, Inc. | 2002-07-18 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165. recall (Z-2196-2010) | Ascent Healthcare Solutions, Inc. | 2010-08-10 |