HEMOCATH
FDA 510(k) clearance K043292 · decided 2005-03-16
Clearance details
- K-number
- K043292
- Device name
- HEMOCATH
- Applicant
- Med-Conduit, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-29
- Decision date
- 2005-03-16
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tyngsboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.