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
K946333Substantially Equivalent

Ibi-1000(Tm) Electrophysiology Cathter

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

K946333 is the FDA 510(k) clearance record for IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER, a class II device, cleared for Irvine Biomedical, Inc. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 12 510(k) clearances for Irvine Biomedical, Inc., from to . As of , FDA records show no recalls naming K946333.

Clearance record

Decision date
Received
(201 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Irvine Biomedical, Inc. 2166 Michelson Dr., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code DRF

Trailing 12 months
1 clearance under product code DRF in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260