The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Stylet, Models 4060, 4062, 4064, 4090, 4091 And 4078.
| Device ID | K090163 |
| 510k Number | K090163 |
| Device Name: | STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 |
| Classification | Stylet, Catheter |
| Applicant | ST. JUDE MEDICAL 15900 VALLEY VIEW COURT Sylmar,, CA 91342 |
| Contact | Geena George |
| Correspondent | Geena George ST. JUDE MEDICAL 15900 VALLEY VIEW COURT Sylmar,, CA 91342 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-22 |
| Decision Date | 2009-04-01 |
| Summary: | summary |