The following data is part of a premarket notification filed by St. Jude Medical, Cardiac Rhythm Management Divisi with the FDA for Mond Rvot Stylet Models 4140, 4141, 4150, 4151.
| Device ID | K080924 |
| 510k Number | K080924 |
| Device Name: | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 |
| Classification | Stylet, Catheter |
| Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342 |
| Contact | Colleen Canan |
| Correspondent | Colleen Canan ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. 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 | 2008-04-02 |
| Decision Date | 2008-04-30 |
| Summary: | summary |