ULTRA-THIN SDS BALLOON DILATATION CATHETER
FDA 510(k) clearance K011909 · decided 2001-11-28
Clearance details
- K-number
- K011909
- Device name
- ULTRA-THIN SDS BALLOON DILATATION CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2001-06-19
- Decision date
- 2001-11-28
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- FGE
- 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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Recalls involving this device
No recalls on record reference this clearance.