SEPTISLEEVE

Catheter, Flow Directed

ARGON MEDICAL CORP.

The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Septisleeve.

Pre-market Notification Details

• Device ID: K820883
• 510k Number: K820883
• Device Name: SEPTISLEEVE
• Classification: Catheter, Flow Directed
• Applicant: ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DYG
• CFR Regulation Number: 870.1240 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-03-30
• Decision Date: 1982-04-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20886333214321	K820883	000