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
K113335Substantially Equivalent

Heartrail III Guiding Catheter

Terumo Corp., Shibuya-Ku, Tokyo, JP / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113335 is the FDA 510(k) clearance record for HEARTRAIL III GUIDING CATHETER, a class II device, cleared for Terumo Corporation on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 34 510(k) clearances for Terumo Corporation, from to . As of , FDA records show no recalls naming K113335.

Clearance record

Decision date
Received
(245 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Corporation 44-1, 2-Chome, Hatagaya, Shibuya-Ku, Tokyo, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQO

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