AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
FDA 510(k) clearance K994208 · decided 2000-01-13
Clearance details
- K-number
- K994208
- Device name
- AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
- Applicant
- Medtronic Perfusion Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-12-14
- Decision date
- 2000-01-13
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.