MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
FDA 510(k) clearance K103353 · decided 2011-01-14
Clearance details
- K-number
- K103353
- Device name
- MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
- Applicant
- Navilyst Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-16
- Decision date
- 2011-01-14
- Days to decision
- 59 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.