NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
FDA 510(k) clearance K121614 · decided 2012-09-18
Clearance details
- K-number
- K121614
- Device name
- NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2012-06-01
- Decision date
- 2012-09-18
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- LJE
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. ( recall (Z-2535-2025) | Boston Scientific Corporation | 2025-09-05 |
| NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M006 recall (Z-1672-2013) | Boston Scientific Corporation | 2013-07-09 |
| NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: recall (Z-1673-2013) | Boston Scientific Corporation | 2013-07-09 |