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

Device, Biopsy, Endomyocardial

21 CFR 870.4075 / Cardiovascular
FDA source (opens on fda.gov)

DWZ is the FDA product code for Device, Biopsy, Endomyocardial, a class II device type, regulated under 21 CFR 870.4075. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DWZ
Device name
Device, Biopsy, Endomyocardial
Regulation
21 CFR 870.4075
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
Yes
Ingested clearances
23
Ingested recalls
1

Clearances, product code DWZ

By decision year
23 clearances under product code DWZ with a decision year between 1981 and 2025, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DWZ by decision year
YearClearances
19811
19871
19883
19892
19901
19912
19922
19931
19941
19951
19972
19991
20001
20011
20071
20171
20251

Applicants with the most clearances

Product code DWZ
Applicants holding the most 510(k) clearances under product code DWZ
ApplicantClearances
Cordis US Corp.5
Annex Medical, Inc.2
Boston Scientific Corporation2
Portlyn Corp.2
Atc Technologies Inc.1
CIVCO Medical Instruments Co., Inc.1
Cook Inc.1
Dlp, Inc.1
FEHLING INSTRUMENTS GmbH1
Fehling Instruments GmbH & Co. KG1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order