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

Catheter, Electrode Recording, Or Probe, Electrode Recording

21 CFR 870.1220 / Cardiovascular
FDA source (opens on fda.gov)

DRF is the FDA product code for Catheter, Electrode Recording, Or Probe, Electrode Recording, a class II device type, regulated under 21 CFR 870.1220. As of , FDA records hold 185 510(k) clearances under this code, the most recent dated , and 26 recalls.

Classification record

Product code
DRF
Device name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
185
Ingested recalls
26

Clearances, product code DRF

By decision year
185 clearances under product code DRF with a decision year between 1977 and 2026, 1995 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code DRF by decision year
YearClearances
19773
19801
19811
19821
19832
19841
19851
19872
19883
19895
19904
19916
19925
19936
19944
199512
19967
19978
19989
19999
20007
20015
20023
20034
20044
20054
20066
20072
20082
20097
20105
20113
20121
20132
20141
20153
20166
20171
20199
20201
20215
20225
20234
20242
20252
20261

Applicants with the most clearances

Product code DRF
Applicants holding the most 510(k) clearances under product code DRF
ApplicantClearances
Biosense Webster Inc19
Abbott Medical18
Boston Scientific Corporation14
Ep Technologies, Inc.12
C.R. Bard Inc11
Irvine Biomedical. Inc.11
Cordis Webster, Inc.8
Medtronic, Inc.7
Innovative Health, LLC.6
Cardima, Inc.5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 63 companies shown, in name order