510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964435Substantially Equivalent

Primary IV Set

Abbott Medical, San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964435 is the FDA 510(k) clearance record for PRIMARY IV SET, a class II device, cleared for Icu Medical, Inc. on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 186 recalls naming K964435.

Clearance record

Decision date
Received
(148 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Icu Medical, Inc. 951 Calle Amanecer, San Clemente CA
510(k) summary
Summary
Third party review
No

Clearances, product code FMG

Trailing 12 months

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

FDA records show no clearances under product code FMG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMG, 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