MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34

Electrosurgical, Cutting & Coagulation & Accessories

BARRX MEDICAL, INCORPORATED

The following data is part of a premarket notification filed by Barrx Medical, Incorporated with the FDA for Modification To: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34.

Pre-market Notification Details

• Device ID: K083711
• 510k Number: K083711
• Device Name: MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale, CA 94085
• Contact: Viorica Filimon
• Correspondent: Viorica Filimon; BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale, CA 94085
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-15
• Decision Date: 2009-02-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521189348	K083711	000
10884521189331	K083711	000
10884521189324	K083711	000
10884521189317	K083711	000
10884521189300	K083711	000
20884521189420	K083711	000
20884521189413	K083711	000