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
20884521581866	K083711	000
20884521581859	K083711	000