MYOCARDIAL PROTECTION SYSTEM

Heat-exchanger, Cardiopulmonary Bypass

QUEST MEDICAL, INC.

The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Myocardial Protection System.

Pre-market Notification Details

• Device ID: K953838
• 510k Number: K953838
• Device Name: MYOCARDIAL PROTECTION SYSTEM
• Classification: Heat-exchanger, Cardiopulmonary Bypass
• Applicant: QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002
• Contact: Drew Johnson
• Correspondent: Drew Johnson; QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002
• Product Code: DTR
• CFR Regulation Number: 870.4240 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-08-16
• Decision Date: 1996-03-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20634624701148	K953838	000
20634624510047	K953838	000
20634624501113	K953838	000
20634624501007	K953838	000
20634624510238	K953838	000
20634624510191	K953838	000
20634624510184	K953838	000
20634624510115	K953838	000
20634624510054	K953838	000
20634624510030	K953838	000
20634624510023	K953838	000
20634624510016	K953838	000
20634624501090	K953838	000
20634624500253	K953838	000
20634624500130	K953838	000
20634624501106	K953838	000
20634624501120	K953838	000
20634624701131	K953838	000
00634624701120	K953838	000
00634624701113	K953838	000
20634624561124	K953838	000
20634624551170	K953838	000
20634624551132	K953838	000
20634624551125	K953838	000
20634624551118	K953838	000
20634624521128	K953838	000
20634624501182	K953838	000
20634624501168	K953838	000
20634624501151	K953838	000
20634624501144	K953838	000
20634624501137	K953838	000
20634624510276	K953838	000