Wolverine Coronary Cutting Balloon H74939401063750

GUDID 08714729888208

Microsurgical Dilatation Device

BOSTON SCIENTIFIC CORPORATION

Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring
Primary Device ID08714729888208
NIH Device Record Keyd31d9f50-d0e7-4a3d-826b-96b14b096949
Commercial Distribution StatusIn Commercial Distribution
Brand NameWolverine Coronary Cutting Balloon
Version Model NumberH74939401063750
Catalog NumberH74939401063750
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729888208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWXCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-13
Device Publish Date2017-11-22

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