CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS— 510(k) K991594
Substantially EquivalentSangstat Medical Corp.
FDA 510(k) clearance K991594 for CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS, Substantially Equivalent on 1999-08-05. Applicant: Sangstat Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Sangstat Medical Corp.
- Product code
- Code MSB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5880
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code MSB
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view allRecalls naming K991594
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991594.
Data sourced from openFDA. This site is unofficial and independent of the FDA.