The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter.
| Device ID | K121614 |
| 510k Number | K121614 |
| Device Name: | NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER |
| Classification | Catheter, Nephrostomy |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Lauren Anderson |
| Correspondent | Lauren Anderson BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2012-09-18 |
| Summary: | summary |