510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K041410Substantially Equivalent

Punctur-Guard Winged Set for Blood Collection, Model 5118

Abbott Medical, Vernon CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K041410 is the FDA 510(k) clearance record for PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118, a class II device, cleared for Icu Medical, Inc. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K041410.

Clearance record

Decision date
Received
(62 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Icu Medical, Inc. 129 Reservoir Rd., Vernon CT
510(k) summary
Statement
Third party review
No

Clearances, product code FPA

Trailing 12 months
6 clearances under product code FPA in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20261
November 20260