510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993189Substantially Equivalent

Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing - 3/8 Inch Tubing

Terumo Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993189 is the FDA 510(k) clearance record for CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING, a class II device, cleared for Terumo Corp. on under FDA product code DWE (Tubing, Pump, Cardiopulmonary Bypass). FDA records list 34 510(k) clearances for Terumo Corp., from to . As of , FDA records show no recalls naming K993189.

Clearance record

Decision date
Received
(160 days to decision)
Product code
DWE Tubing, Pump, Cardiopulmonary Bypass
Regulation
21 CFR 870.4390
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Corp. 125 Blue Ball Rd., Elkton MD
510(k) summary
Summary
Third party review
No

Clearances, product code DWE

Trailing 12 months

FDA records hold no clearances under product code DWE in the trailing twelve months.

FDA records show no clearances under product code DWE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260