FDA.reportPublic FDA data

WOLF Thrombectomy SmartClaw Catheter

Primary DI
00850029546009
Brand
WOLF Thrombectomy SmartClaw Catheter
Company
Devoro Medical Inc.
Model
FD0660-01
Device description
WOLF Thrombectomy SmartClaw Catheter, 20mm
Published
2023-07-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850029546009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029546009008500295460098500295460090850029546009

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter20Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117672411
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850029546023WOLF Thrombectomy System, 14FFD0364-022023-07-12
00850029546030WOLF Thrombectomy System, 14FFD0364-032023-07-12
00850029546047WOLF Thrombectomy System, 14FFD0364-042023-07-12
00850029546054WOLF Thrombectomy System, 14FFD0364-052023-07-12
00850029546115WOLF Thrombectomy Reload Pack, 14FFD0364-112023-07-12
00850029546153WOLF Thrombectomy Sheath, 14FFD0381-132023-07-12
00850029546221WOLF Thrombectomy SmartClaw CatheterFD0660-022023-07-12
00850029546184WOLF Thrombectomy System, 6FFD0427-022022-10-12
00850029546214WOLF Devortex Reload Pack, 6FFD0427-122022-10-12
00850029546238WOLF Thrombectomy System, 7FFD0427-042022-10-12
00850029546245WOLF Thrombectomy System, 8FFD0427-052022-10-12
00850029546252WOLF Devortex Reload Pack, 7FFD0427-132022-10-12
00850029546269WOLF Devortex Reload Pack, 8FFD0427-142022-10-12

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00191506067380TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067397TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067403TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067410TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
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00884450826492Fountain®Merit Medical Systems, Inc.KRA2026-05-29
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
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