510(k) Report

FDA applicant

Medtronic Cardiorhythm

San Jose, CA5 decisions1994–19980 recalls

FDA records 5 decisions for Medtronic Cardiorhythm (San Jose, CA) from 1994 to 1998: 5 510(k) clearances. All are in product code DRF (Catheter, Electrode Recording, Or Probe…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Medtronic Cardiorhythm’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Cardiorhythm since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medtronic Cardiorhythm by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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