14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
FDA 510(k) clearance K021759 · decided 2002-08-27
Clearance details
- K-number
- K021759
- Device name
- 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
- Applicant
- Medcomp
- Decision
- Unknown
- Date received
- 2002-05-29
- Decision date
- 2002-08-27
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.