510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K083834Substantially Equivalent

Terumo Pall Al6x Arterial Filter

Terumo Cardiovascular Systems Corporation, Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083834 is the FDA 510(k) clearance record for TERUMO PALL AL6X ARTERIAL FILTER, a class II device, cleared for Terumo Cardiovascular Systems Corp. on under FDA product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line). FDA records list 160 510(k) clearances for Terumo Cardiovascular Systems Corp., from to . As of , FDA records show no recalls naming K083834.

Clearance record

Decision date
Received
(115 days to decision)
Product code
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Regulation
21 CFR 870.4260
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Cardiovascular Systems Corp. 125 Blue Ball Rd., Elkton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTM

Trailing 12 months
1 clearance under product code DTM in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTM, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260