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 |