PERFADEX WITH THAM
FDA 510(k) clearance K081997 · decided 2008-10-09
Clearance details
- K-number
- K081997
- Device name
- PERFADEX WITH THAM
- Applicant
- Vitrolife Sweden AB
- Decision
- Substantially Equivalent
- Date received
- 2008-07-14
- Decision date
- 2008-10-09
- Days to decision
- 87 days
- Clearance type
- Special
- Product code
- MSB
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kungsbacka, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Ster recall (Z-2795-2011) | Vitrolife, Inc. | 2011-07-12 |