The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Enlightn Renal Guide Catheter.
| Device ID | K131592 |
| 510k Number | K131592 |
| Device Name: | ENLIGHTN RENAL GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL, INC. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Contact | Blair Schwartz |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2014-01-31 |
| Summary: | summary |