FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

W.L. GORE & ASSOCIATES,INC

The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Fep Ringed Gore-tex Stretch Vascular Graft.

Pre-market Notification Details

• Device ID: K922905
• 510k Number: K922905
• Device Name: FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
• Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Applicant: W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff, AZ 86001
• Contact: James D Lewis
• Correspondent: James D Lewis; W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff, AZ 86001
• Product Code: DSY
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Se - Postmarket Surveillance Required (SESP)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-06-16
• Decision Date: 1992-11-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H373SRT08012030L3L	K922905	000
H373SRD06005045L3B	K922905	000