PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

POSSIS MEDICAL, INC.

The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Perma-pass Vascular Graft, 6s Graft,model 31453, 6t Graft,model 31452.

Pre-market Notification Details

• Device ID: K984182
• 510k Number: K984182
• Device Name: PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
• Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Applicant: POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003
• Contact: Timothy J Kappers
• Correspondent: Timothy J Kappers; POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003
• Product Code: DSY
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-11-23
• Decision Date: 1999-02-01
• Summary: summary