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

Device, Counter-Pulsating, External

21 CFR 870.5225 / Cardiovascular
FDA source (opens on fda.gov)

DRN is the FDA product code for Device, Counter-Pulsating, External, a class II device type, regulated under 21 CFR 870.5225. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DRN
Device name
Device, Counter-Pulsating, External
Regulation
21 CFR 870.5225
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
34
Ingested recalls
1

Clearances, product code DRN

By decision year
34 clearances under product code DRN with a decision year between 1980 and 2025, 2003 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code DRN by decision year
YearClearances
19802
19841
19871
19891
19951
19971
20002
20012
20023
20037
20042
20051
20061
20081
20091
20131
20151
20181
20191
20202
20251

Applicants with the most clearances

Product code DRN
Applicants holding the most 510(k) clearances under product code DRN
ApplicantClearances
Cardiomedics, Inc.5
Circulator Boot Corp.4
Vasomedical, Inc.3
External Counterpulsation Lab2
Living Data Technologies Corporation2
Nicore Equipment & Leasing, Inc.2
Vamed Medical Instrument Co.,Ltd2
Applied Cardiac Systems1
Cardiassist Corp.1
Chongqing Psk Sci-Tech Development Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code