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
K033569Substantially Equivalent

Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath

Flowmedica, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033569 is the FDA 510(k) clearance record for FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH, a class II device, cleared for Flowmedica, Inc. on under FDA product code KRA (Catheter, Continuous Flush). FDA records list 3 510(k) clearances for Flowmedica, Inc., from to . As of , FDA records show 2 recalls naming K033569.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
Flowmedica, Inc. 46563 Fremont Blvd., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRA

Trailing 12 months
5 clearances under product code KRA in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRA, 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 20262
October 20260