PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
FDA 510(k) clearance K980762 · decided 1998-09-01
Clearance details
- K-number
- K980762
- Device name
- PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
- Applicant
- Pall Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-27
- Decision date
- 1998-09-01
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- East Hills, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.