ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
FDA 510(k) clearance K963397 · decided 1996-11-25
Clearance details
- K-number
- K963397
- Device name
- ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1996-08-29
- Decision date
- 1996-11-25
- Days to decision
- 88 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
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5 recall (Z-1210-2010) | Boston Scientific Corporation | 2010-03-25 |