BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
FDA 510(k) clearance K092032 · decided 2009-12-08
Clearance details
- K-number
- K092032
- Device name
- BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-06
- Decision date
- 2009-12-08
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- FTL
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Warwick, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft t recall (Z-0191-2015) | Davol, Inc., Subs. C. R. Bard, Inc. | 2014-11-07 |
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|---|---|---|
| Avitene Flowable Collagen Hemostat (N17600/S043) | Davol Inc., Sub. C. R. Bard, Inc. | 2025-06-10 |
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| Avitene Microfibrillar Collagen Hemostat (N17600/S038) | Davol Inc., Sub. C. R. Bard, Inc. | 2023-04-25 |