RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250— 510(k) K982712
Substantially EquivalentGenzyme Surgical Product (Genzyme Biosurgery)
FDA 510(k) clearance K982712 for RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250, Substantially Equivalent on 1998-12-18. Applicant: Genzyme Surgical Product (Genzyme Biosurgery).
Clearance details
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Product code
- Code CAC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fall River, MA, US
Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.