510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981642Substantially Equivalent

Stablemapr Steerable Intracardiac Catheters

Medtronic Cardiorhythm, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981642 is the FDA 510(k) clearance record for STABLEMAPR STEERABLE INTRACARDIAC CATHETERS, a class II device, cleared for Medtronic Cardiorhythm on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 5 510(k) clearances for Medtronic Cardiorhythm, from to . As of , FDA records show no recalls naming K981642.

Clearance record

Decision date
Received
(89 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
Medtronic Cardiorhythm 1312 Crossman Ave., Sunnyvale 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