15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706
FDA 510(k) clearance K040992 · decided 2004-07-29
Clearance details
- K-number
- K040992
- Device name
- 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706
- Applicant
- Medcomp
- Decision
- Unknown
- Date received
- 2004-04-16
- Decision date
- 2004-07-29
- Days to decision
- 104 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.