510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K070011Substantially Equivalent

Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter

Irvine Biomedical,Inc.(Ibi), Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070011 is the FDA 510(k) clearance record for IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER, a class II device, cleared for Irvine Biomedical,Inc.(Ibi) on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list one 510(k) clearance for Irvine Biomedical,Inc.(Ibi). As of , FDA records show no recalls naming K070011.

Clearance record

Decision date
Received
(76 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Irvine Biomedical,Inc.(Ibi) 2375 Morse Ave., Irvine CA
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