HEMO-CATH 10F, HEMO-CATH 12.5F
FDA 510(k) clearance K113487 · decided 2012-03-09
Clearance details
- K-number
- K113487
- Device name
- HEMO-CATH 10F, HEMO-CATH 12.5F
- Applicant
- Medical Components, Inc.
- Decision
- Unknown
- Date received
- 2011-11-23
- Decision date
- 2012-03-09
- Days to decision
- 107 days
- Clearance type
- Special
- 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.