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

Stripper, Artery, Intraluminal

21 CFR 870.4875 / Cardiovascular
FDA source (opens on fda.gov)

DWX is the FDA product code for Stripper, Artery, Intraluminal, a class II device type, regulated under 21 CFR 870.4875. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DWX
Device name
Stripper, Artery, Intraluminal
Regulation
21 CFR 870.4875
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
14
Ingested recalls
0

Clearances, product code DWX

By decision year
14 clearances under product code DWX with a decision year between 1980 and 2012, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DWX by decision year
YearClearances
19801
19841
19892
19902
19911
19921
19941
19951
20011
20032
20121

Applicants with the most clearances

Product code DWX
Applicants holding the most 510(k) clearances under product code DWX
ApplicantClearances
Olympus Corp.2
American Sterilizer Co.1
Applied Medical Resources Corp1
Baxter Healthcare Corporation1
Cardio Vascular Concepts, Inc.1
Endarx, Inc.1
Endo Surgical Devices, Inc.1
Intensive Technology, Inc.1
LeMaitre Vascular Inc.1
Omni-Tract Surgical, Div. Minn. Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code