QUINTON SINGLE LUMEN CATHETER
FDA 510(k) clearance K893188 · decided 1989-06-08
Clearance details
- K-number
- K893188
- Device name
- QUINTON SINGLE LUMEN CATHETER
- Applicant
- Quinton, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-05
- Decision date
- 1989-06-08
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- MPB
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.