QUART ARTERIAL FILTER, MODEL HBF 140
FDA 510(k) clearance K001787 · decided 2000-06-30
Clearance details
- K-number
- K001787
- Device name
- QUART ARTERIAL FILTER, MODEL HBF 140
- Applicant
- Jostra Medizintechnik AG
- Decision
- Substantially Equivalent
- Date received
- 2000-06-13
- Decision date
- 2000-06-30
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.