BVI SLING
FDA 510(k) clearance K002233 · decided 2000-10-13
Clearance details
- K-number
- K002233
- Device name
- BVI SLING
- Applicant
- Bio-Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-24
- Decision date
- 2000-10-13
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- PAJ
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Paul, 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 |
|---|---|---|
| XENFORM SOFT TISSUE REPAIR MATRIX (K051190) | Tei Biosciences, Inc. | 2005-06-10 |
Recalls involving this device
No recalls on record reference this clearance.