AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
FDA 510(k) clearance K131814 · decided 2013-07-26
Clearance details
- K-number
- K131814
- Device name
- AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
- Applicant
- Ameco Medical Industries
- Decision
- Unknown
- Date received
- 2013-06-20
- Decision date
- 2013-07-26
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Monroe, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.