CROC

Clamp, Vascular

COMBAT MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Combat Medical Systems, Llc with the FDA for Croc.

Pre-market Notification Details

• Device ID: K141685
• 510k Number: K141685
• Device Name: CROC
• Classification: Clamp, Vascular
• Applicant: COMBAT MEDICAL SYSTEMS, LLC 400 N. WASHINGTON STREET, SUITE 100 Alexandria, VA 22314
• Contact: Calley Herzog
• Correspondent: Calley Herzog; COMBAT MEDICAL SYSTEMS, LLC 400 N. WASHINGTON STREET, SUITE 100 Alexandria, VA 22314
• Product Code: DXC
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-06-23
• Decision Date: 2015-01-26
• Summary: summary