FDA.reportPublic FDA data

ZILIENT

Primary DI
10852528005572
Brand
ZILIENT
Company
Cardiovascular Systems, Inc.
Model
30G-195-014
Catalog number
7-10050-05
Device description
"30gram tip, short taper, .014"" diameter 195cm"
Published
2018-03-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCWCatheter, Peripheral, Atherectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCWCatheter, Peripheral, AtherectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30852528005576PackageGS15Not in Commercial Distribution
10852528005572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085252800557630852528005576
1085252800557210852528005572

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It 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

Contacts#

Phone, Email table
PhoneEmail
651-259-1600customerservice@csi360.com
877-274-0360customerservice@csi360.com

Regulatory Flags#

DUNS number
024954518
Device count
1
Lot or batch
true
Expiration date on label
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
07290017590264AuryonEXIMO MEDICAL LTDMCW2026-06-02
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183865PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
00857141005322Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005339Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005346Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005377Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005384Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005391Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005407Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005414Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00810060550793Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2025-10-21
00810060550809Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2025-10-21
00763000835392HawkOne™MEDTRONIC, INC.MCW2024-12-28
07290017590325Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
07290017590332Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
00763000918934TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918941TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918958TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918910SilverHawk™MEDTRONIC, INC.MCW2024-08-10
00763000918927SilverHawk™MEDTRONIC, INC.MCW2024-08-10
00763000918965Cutter DriverMEDTRONIC, INC.MCW2024-08-10
00845225003463Phoenix 1.5mm x 149cm 4F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003470Phoenix 1.8mm x 130cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003487Phoenix 1.8mm x 149cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003494Phoenix 2.2mm x 130cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003500Phoenix 2.2mm x 149cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003517Phoenix 2.2mm x 130cm 6F Pre-Deflected Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08