510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153093Substantially Equivalent

FIRMap Catheter

Abbott Electrophysiology, Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153093 is the FDA 510(k) clearance record for FIRMap Catheter, a class II device, cleared for Abbott Electrophysiology on under FDA product code MTD (Catheter, Intracardiac Mapping, High-Density Array). FDA records list 4 510(k) clearances for Abbott Electrophysiology, from to . As of , FDA records show no recalls naming K153093.

Clearance record

Decision date
Received
(164 days to decision)
Product code
MTD Catheter, Intracardiac Mapping, High-Density Array
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Abbott Electrophysiology 1530 Obrien Dr., Suite B, Menlo Park CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MTD

Trailing 12 months
2 clearances under product code MTD 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 MTD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260