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 |