FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
K Number: K991594
·
Decision Aug 5, 1999
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
12
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
- K Number
- K991594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sangstat Medical Corp.
- Date Received
- May 7, 1999
- Decision Date
- August 5, 1999
- Product Code
- MSB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Expedited Review
- Y
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | FDA class 2 | Gastroenterology, Urology |
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