CARDIOPULMONARY BYPASS TUBING

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

TEXAS MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Cardiopulmonary Bypass Tubing.

Pre-market Notification Details

• Device ID: K801401
• 510k Number: K801401
• Device Name: CARDIOPULMONARY BYPASS TUBING
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: TEXAS MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-06-13
• Decision Date: 1980-06-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B066RCB020	K801401	000
B066SFB023	K801401	000
B066SFB043	K801401	000
B066SFB063	K801401	000
B066SFB083	K801401	000
B066SFB103	K801401	000
B066SFB123	K801401	000
B066SFC023	K801401	000
B066SFC043	K801401	000
B066SFC063	K801401	000
B066SDC123	K801401	000
B066SDC103	K801401	000
B066SDC083	K801401	000
B066RDB020	K801401	000
B066RDC020	K801401	000
B066RFB020	K801401	000
B066RFC020	K801401	000
B066RHC020	K801401	000
B066RHC040	K801401	000
B066SDB143	K801401	000
B066SDC043	K801401	000
B066SDC063	K801401	000
B066SFC080	K801401	000
B066SFC103	K801401	000
B0663110060003	K801401	000
B0663110070003	K801401	000
B066SCB063	K801401	000
B066SCB083	K801401	000
B066SDB023	K801401	000
B066SDB043	K801401	000
B066SDB060	K801401	000
B066SDB083	K801401	000
B066SDB103	K801401	000
B0663110050003	K801401	000
B0663110040003	K801401	000
B0663110030003	K801401	000
B066SFC123	K801401	000
B066SHC023	K801401	000
B066SHC043	K801401	000
B066SHC063	K801401	000
B066SHC083	K801401	000
B066SHC103	K801401	000
B066VAVRSCP3	K801401	000
B0663110010000	K801401	000
B0663110020003	K801401	000
B066SDB123	K801401	000