510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010471Substantially Equivalent

Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569

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

K010471 is the FDA 510(k) clearance record for AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569, 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 K010471.

Clearance record

Decision date
Received
(106 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. 2146-A 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