510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K192267Substantially Equivalent

ILUMIEN System with AptiVue Software version D.3

Abbott Medical, Westford MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192267 is the FDA 510(k) clearance record for ILUMIEN System with AptiVue Software version D.3, a class II device, cleared for ABBOTT MEDICAL on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 1,478 510(k) clearances for ABBOTT MEDICAL, from to . As of , FDA records show no recalls naming K192267.

Clearance record

Decision date
Received
(118 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Abbott Medical 4 Robbins Rd., Westford MA
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