The following data is part of a premarket notification filed by St Jude Medical, Inc with the FDA for The Nanostim Introducer Kit.
| Device ID | K160716 |
| 510k Number | K160716 |
| Device Name: | The Nanostim Introducer Kit |
| Classification | Introducer, Catheter |
| Applicant | St Jude Medical, Inc 645 Almanor Avenue Sunnyvale, CA 94085 |
| Contact | Brittany Cunningham |
| Correspondent | Hassan Labay St Jude Medical, Inc 645 Almanor Avenue Sunnyvale, CA 94085 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-15 |
| Decision Date | 2016-04-14 |
| Summary: | summary |