The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Nanostim Introducer Kit.
| Device ID | K140793 |
| 510k Number | K140793 |
| Device Name: | NANOSTIM INTRODUCER KIT |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL, INC. 776 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Contact | Hassan Labay |
| Correspondent | Hassan Labay ST. JUDE MEDICAL, INC. 776 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-31 |
| Decision Date | 2014-12-17 |
| Summary: | summary |