FLO-THRU

Clamp, Vascular

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Flo-thru.

Pre-market Notification Details

• Device ID: K981624
• 510k Number: K981624
• Device Name: FLO-THRU
• Classification: Clamp, Vascular
• Applicant: BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024
• Contact: D.e. Gardner
• Correspondent: D.e. Gardner; BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024
• Product Code: DXC
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-05-07
• Decision Date: 1998-08-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50085412532511	K981624	000
50085412532504	K981624	000
50085412532498	K981624	000
50085412532481	K981624	000
50085412532474	K981624	000
50085412532467	K981624	000
50085412532450	K981624	000
50085412532443	K981624	000
50085412532436	K981624	000