REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804

Catheter, Electrode Recording, Or Probe, Electrode Recording

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Reflexion Spiral Variable Radius Catheter, Model 402804.

Pre-market Notification Details

• Device ID: K062251
• 510k Number: K062251
• Device Name: REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
• Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
• Applicant: ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126
• Contact: Glenn Jacques
• Correspondent: Glenn Jacques; ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126
• Product Code: DRF
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-08-03
• Decision Date: 2006-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05414734206204	K062251	000