GISH ARTERIAL FILTER WITH GBS COATING
FDA 510(k) clearance K023833 · decided 2003-03-31
Clearance details
- K-number
- K023833
- Device name
- GISH ARTERIAL FILTER WITH GBS COATING
- Applicant
- Gish Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-18
- Decision date
- 2003-03-31
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.