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Panels › Cardiovascular › Product code DRE · Class 2

Dilator, Vessel, For Percutaneous Catheterization

Regulation 870.1310

2510(k)s in 12 months (105 all time)
1recalls in 12 months (40 all time)
36recalls that name a 510(k)
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Top companies in DRE

Company510(k)sRecalls
Merit Medical Systems, Inc.106
Angiodynamics, Inc.015
Spectranetics Corp.90
Boston Scientific Corp16
Galt Medical Corp.33
Argon Medical Devices, Inc05
Baylis Medical Company, Inc.50
Cook Vascular, Inc.40
Cook Incorporated30
Cordis Corp.12
Decided510(k)Device and applicantCode
Oct 10, 1980K802327SHEATH DILATOR SET
Stanco Medical, Inc.
DRE
Jul 28, 1980K801113DILATOR, VESSEL, FOR PERC. CATHETER.
Alva Medical, Inc.
DRE
Mar 19, 1980K800462PERCUTANEOUS INTRODUCER SET
Medical Components, Inc.
DRE
Mar 2, 1978K780126DILATOR, VESSEL & INTRODUCER, SHEATH
Argon Medical Corp.
DRE
Aug 23, 1976K760403TEMPORARY ATRIAL ELECTRODE KIT
Usci, Div. C.R. Bard, Inc.
DRE

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