FDA.reportPublic FDA data

Diamondback Coronary

Primary DI
30852528005705
Brand
Diamondback Coronary
Company
Cardiovascular Systems, Inc.
Model
GWC-12325LG-FT
Catalog number
7-10038-01
Device description
Guidewire, Viperwire Advance Coronary Flex Tip .014: dia, .012" 1 Pack 325 cm
Published
2019-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
P130005021

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130005021DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEMCardiovascular Systems, Inc.2013-10-21MCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30852528005705PackageGS15In Commercial Distribution
10852528005701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085252800570530852528005705
1085252800570110852528005701

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
877-274-0360customerservice@csi360.com

Regulatory Flags#

DUNS number
024954518
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10852528005817Diamondback PeripheralDBP-EX-125MIC1457-10030-012019-02-04
10852528005824Diamondback PeripheralDBP-EX-125SOL1457-10030-022019-02-04
10852528005831Diamondback PeripheralDBP-EX-150SOL1457-10030-032019-02-04
10852528005848Diamondback PeripheralDBP-EX-200SOL1457-10030-042019-02-04
10852528005862Diamondback PeripheralDBP-EX-125SOL757-10030-062019-02-04
10852528005879Diamondback PeripheralDBP-EX-125SOL2007-10030-072019-02-04
10852528005886Diamondback PeripheralDBP-EX-150SOL2007-10030-082019-02-04
10852528005893Diamondback PeripheralDBP-EX-175SOL1807-10030-092019-02-04
10852528005909Diamondback PeripheralDBP-EX-150CLA1457-10030-102019-02-04
10852528005916Diamondback PeripheralDBP-EX-200CLA1457-10030-112019-02-04
10852528005855Diamondback PeripheralDBP-EX-125MIC757-10030-052019-02-04
10850000491172Diamondback PeripheralDBP-125MICRO1457-10057-012019-11-13
10850000491189Diamondback PeripheralDBP-125SOLID1457-10057-022019-11-13
10850000491196Diamondback PeripheralDBP-150SOLID1457-10057-032019-11-13
10850000491202Diamondback PeripheralDBP-200SOLID1457-10057-042019-11-13
10850000491219Diamondback PeripheralDBP-125SOLID2007-10057-052019-11-13
10850000491226Diamondback PeripheralDBP-150SOLID2007-10057-062019-11-13
10850000491233Diamondback PeripheralDBP-175SOLID1807-10057-072019-11-13
10850000491240Diamondback PeripheralDBP-150CLASS1457-10057-082019-11-13
10850000491257Diamondback PeripheralDBP-200CLASS1457-10057-092019-11-13

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
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
08714729893424ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11