LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2

Catheter, Electrode Recording, Or Probe, Electrode Recording

BIOSENSE WEBSTER, INC.

The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2.

Pre-market Notification Details

• Device ID: K113213
• 510k Number: K113213
• Device Name: LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
• Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
• Applicant: BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD Diamond Bar, CA 91765
• Contact: John Jimenez
• Correspondent: John Jimenez; BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD Diamond Bar, CA 91765
• Product Code: DRF
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-01
• Decision Date: 2011-12-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10846835009712	K113213	000
10846835009644	K113213	000
10846835010046	K113213	000
10846835009637	K113213	000
10846835009668	K113213	000
10846835009675	K113213	000
10846835009682	K113213	000
10846835009699	K113213	000
10846835009705	K113213	000
10846835009651	K113213	000