← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1220
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 4 · pma: 1
0
RECALL ENTRIES

Recent clearances

K252794Imricor Medical Systems, Inc. · 510k2026-01-08
K250590Stereotaxis, Inc. · 510k2025-07-23
K250310Boston Scientific Corporation · 510k2025-06-27
P990025Biosense Webster, Inc. · pma2025-02-25
K240366Boston Scientific Corporation · 510k2024-11-01

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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