FDA.reportPublic FDA data

RotaWire™ and wireClip™ Torquer

Primary DI
08714729144168
Brand
RotaWire™ and wireClip™ Torquer
Company
BOSTON SCIENTIFIC CORPORATION
Model
H802232390010
Catalog number
H802232390010
Device description
Guidewire and Guidewire Manipulation Device
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MCXCATHETER, CORONARY, ATHERECTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCXCatheter, Coronary, AtherectomyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P900056000
P900056008
P900056009
P900056010
P900056011
P900056012
P900056014
P900056015
P900056017
P900056018
P900056019
P900056020
P900056021
P900056022
P900056023
P900056025
P900056027
P900056029
P900056036
P900056037
P900056041
P900056047
P900056049
P900056052
P900056062
P900056066
P900056067
P900056068
P900056078
P900056083
P900056090
P900056094
P900056104
P900056106
P900056107
P900056139
P900056221

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900056000ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056008ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056009ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056010ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056011ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056012ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056014ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056015ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056017ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056018ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056019ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056020ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056021ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056022ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056023ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056025ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056027ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056029ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056036ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056037ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056041ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056047ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056049ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056052ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056062ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056066ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056067ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056068ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056078ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056083ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056090ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056094ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056104ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056106ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056107ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056139ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056221ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729195573PackageGS15In Commercial Distribution
08714729144168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729195573087147291955738714729195573
08714729144168087147291441688714729144168

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
021717889
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506005559Rotaglide™BOSTON SCIENTIFIC CORPORATIONMCX2023-11-03
00191506005566Rotaglide™BOSTON SCIENTIFIC CORPORATIONMCX2023-11-03
10850026568698Diamondback CoronaryCardiovascular Systems, Inc.MCX2023-06-16
10850026568087Diamondback CoronaryCardiovascular Systems, Inc.MCX2021-05-07
10850026568100Diamondback CoronaryCardiovascular Systems, Inc.MCX2021-05-07
08714729996231RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729996255RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729996248RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729996262RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729999560ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999577ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999584ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999591ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999607ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999614ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999621ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999638ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
10850000491356Diamondback CoronaryCardiovascular Systems, Inc.MCX2020-03-05
10850000491363Diamondback CoronaryCardiovascular Systems, Inc.MCX2020-03-05
10852528005701ViperWireCardiovascular Systems, Inc.MCX2019-09-23
30852528005705Diamondback CoronaryCardiovascular Systems, Inc.MCX2019-09-23
10852528005787Diamondback CoronaryCardiovascular Systems, Inc.MCX2019-02-04
10852528005800Diamondback CoronaryCardiovascular Systems, Inc.MCX2018-07-20
08714729893356ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893363ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893370ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893387ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893394ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893400ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893417ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11