FDA.reportPublic FDA data

Stealth

Primary DI
10850000491271
Brand
Stealth
Company
Cardiovascular Systems, Inc.
Model
PRD-SC30-125
Catalog number
7-10059-02
Device description
STEALTH PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT, 120 KRPM HIGH SPEED, 90 KRPM MEDIUM SPEED, 60 KRPM LOW SPEED
Published
2019-09-10
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

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
10850000491271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085000049127110850000491271

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system catheter, peripheralA sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. 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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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
+1(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
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
00845225003524Phoenix 2.4mm x 130cm 7F Pre-Deflected Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08