PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

PIONEERING TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Anastomark Flexible Coronary Bypass Graft.

Pre-market Notification Details

• Device ID: K905067
• 510k Number: K905067
• Device Name: PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT
• Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Applicant: PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033
• Contact: Wright
• Correspondent: Wright; PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033
• Product Code: DSY
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-09
• Decision Date: 1991-03-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B040FMPM32	K905067	000
B040FMPM22	K905067	000
B040FMPM12	K905067	000