FDA.reportPublic FDA data

RotaWire™ and wireClip™ Torquer

Primary DI
08714729195573
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
OTC
false
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900056000ROTABLATOR(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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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08714729893370ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
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