PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP

Instruments, Surgical, Cardiovascular

PIONEERING TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Intra-art Coronary Artery Retraction Clip.

Pre-market Notification Details

• Device ID: K882981
• 510k Number: K882981
• Device Name: PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP
• Classification: Instruments, Surgical, Cardiovascular
• Applicant: PIONEERING TECHNOLOGIES, INC. 143 UNION BLVD., SUITE 900 Lakewood, CO 80228
• Contact: Wright,phd
• Correspondent: Wright,phd; PIONEERING TECHNOLOGIES, INC. 143 UNION BLVD., SUITE 900 Lakewood, CO 80228
• Product Code: DWS
• CFR Regulation Number: 870.4500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-07-15
• Decision Date: 1988-09-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B040CRC52	K882981	000
B040CRC32	K882981	000