PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET

Controller, Temperature, Cardiopulmonary Bypass

PIONEERING TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Heart-chill(tm) Cardiac Insulating Jacket.

Pre-market Notification Details

• Device ID: K874927
• 510k Number: K874927
• Device Name: PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
• Classification: Controller, Temperature, Cardiopulmonary Bypass
• Applicant: PIONEERING TECHNOLOGIES, INC. C/O BUCKMAN COMPANY, INC. 921 CALLE VERDE Martinez, CA 94553
• Contact: David W Schlerg
• Correspondent: David W Schlerg; PIONEERING TECHNOLOGIES, INC. C/O BUCKMAN COMPANY, INC. 921 CALLE VERDE Martinez, CA 94553
• Product Code: DWC
• CFR Regulation Number: 870.4250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-12-02
• Decision Date: 1988-01-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B040CPIS1	K874927	000
B040CPIM26	K874927	000
B040CPIL25	K874927	000