CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR

Oxygenator, Cardiopulmonary Bypass

TERUMO CARDIOVASCULAR SYSTEMS CORP.

The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Capix Rx Hollow Fiber Oxygenator With/without Hardshell Reservoir.

Pre-market Notification Details

• Device ID: K130333
• 510k Number: K130333
• Device Name: CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
• Classification: Oxygenator, Cardiopulmonary Bypass
• Applicant: TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Contact: Suzanne Grenier
• Correspondent: Suzanne Grenier; TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Product Code: DTZ
• CFR Regulation Number: 870.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2013-02-11
• Decision Date: 2013-03-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50699753450153	K130333	000
50699753450146	K130333	000
50699753450139	K130333	000
50699753450122	K130333	000
50699753450115	K130333	000
50699753450108	K130333	000