The following data is part of a premarket notification filed by St Jude Medical, Inc. with the FDA for Nanostim Introducer Kit.
| Device ID | K161102 |
| 510k Number | K161102 |
| Device Name: | Nanostim Introducer Kit |
| Classification | Introducer, Catheter |
| Applicant | ST JUDE MEDICAL, INC. 15900 VALLEY VIEW CT Sylmar, CA 91342 |
| Contact | Hassan Labay |
| Correspondent | Hassan Labay ST. JUDE MEDICAL 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 | 2016-04-19 |
| Decision Date | 2016-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067027535 | K161102 | 000 |