TERUMO PALL AL6X ARTERIAL FILTER

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

TERUMO CARDIOVASCULAR SYSTEMS CORP.

The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Terumo Pall Al6x Arterial Filter.

Pre-market Notification Details

• Device ID: K083834
• 510k Number: K083834
• Device Name: TERUMO PALL AL6X ARTERIAL FILTER
• Classification: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
• Applicant: TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Contact: Eileen Dorsey
• Correspondent: Eileen Dorsey; TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Product Code: DTM
• CFR Regulation Number: 870.4260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-23
• Decision Date: 2009-04-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50699753450016	K083834	000