IMPACT BALLOON DILATION CATHETER
FDA 510(k) clearance K983373 · decided 1999-06-22
Clearance details
- K-number
- K983373
- Device name
- IMPACT BALLOON DILATION CATHETER
- Applicant
- B. Braun/Mcgaw
- Decision
- Substantially Equivalent
- Date received
- 1998-09-24
- Decision date
- 1999-06-22
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- KNQ
- Device class
- 2
- Regulation number
- 876.5365
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, recall (Z-0509-2010) | Numed Inc | 2009-12-15 |