TRIPLE LUMEN INFUSION CATHETER/ACCESS
FDA 510(k) clearance K841535 · decided 1984-05-23
Clearance details
- K-number
- K841535
- Device name
- TRIPLE LUMEN INFUSION CATHETER/ACCESS
- Applicant
- Gish Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-27
- Decision date
- 1984-05-23
- Days to decision
- 86 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.