CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
FDA 510(k) clearance K991594 · decided 1999-08-05
Clearance details
- K-number
- K991594
- Device name
- CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
- Applicant
- Sangstat Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-07
- Decision date
- 1999-08-05
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MSB
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- Yes
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Mode recall (Z-2220-2025) | INSTITUT GEORGES LOPEZ | 2025-07-30 |