ENDOSCOPIC BILIARY CATHETER
FDA 510(k) clearance K946358 · decided 1995-04-11
Clearance details
- K-number
- K946358
- Device name
- ENDOSCOPIC BILIARY CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1994-12-30
- Decision date
- 1995-04-11
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- LQR
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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