X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR

Oxygenator, Cardiopulmonary Bypass

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for X-coated Capiox Sx18 And Sx25 Hollow Fiber Oxygenator With/ Without Detachable Hardshell Reservoir.

Pre-market Notification Details

• Device ID: K993772
• 510k Number: K993772
• Device Name: X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
• Classification: Oxygenator, Cardiopulmonary Bypass
• Applicant: TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Contact: Garry A Courtney
• Correspondent: Garry A Courtney; TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Product Code: DTZ
• CFR Regulation Number: 870.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-08
• Decision Date: 2000-06-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50699753450085	K993772	000
50699753450047	K993772	000