MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151

Stylet, Catheter

ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI

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.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05414734505451	K080924	000
05414734503396	K080924	000
05414734503402	K080924	000
05414734503419	K080924	000
05414734504003	K080924	000
05414734504010	K080924	000
05414734504027	K080924	000
05414734504034	K080924	000
05414734504041	K080924	000
05414734504058	K080924	000
05414734504065	K080924	000
05414734504072	K080924	000
05414734505420	K080924	000
05414734505437	K080924	000
05414734505444	K080924	000
05414734502702	K080924	000