COBE VACUUM RELIEF CHECK VALVE

Cpb Check Valve, Retrograde Flow, In-line

COBE CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Vacuum Relief Check Valve.

Pre-market Notification Details

• Device ID: K982406
• 510k Number: K982406
• Device Name: COBE VACUUM RELIEF CHECK VALVE
• Classification: Cpb Check Valve, Retrograde Flow, In-line
• Applicant: COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004
• Contact: Lynne Leonard
• Correspondent: Lynne Leonard; COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004
• Product Code: MJJ
• CFR Regulation Number: 870.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-10
• Decision Date: 1998-10-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10803622123419	K982406	000