FDA.reportPublic FDA data

QuickClear Thrombectomy System

Primary DI
00845225003104
Brand
QuickClear Thrombectomy System
Company
Volcano Atheromed, Inc.
Model
AC8ST085
Catalog number
AC8ST085
Device description
QuickClear Mechanical Thrombectomy System, 8F, 85 cm, straight tip
Published
2022-01-19
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
QEZAspiration Thrombectomy Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEZAspiration Thrombectomy CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193197000QuickClear Mechanical Thrombectomy SystemVolcano Atheromed, Inc.2020-04-20QEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225003104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225003104008452250031048452250031040845225003104

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA sterile 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 and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length85Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
788341084
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225003005QuickClear Aspiration PumpP3223ASPP3223ASP2020-06-11
00845225003012QuickClear Aspiration PumpP3223P32232020-06-11
00845225003081QuickClear Thrombectomy SystemAC6ST130AC6ST1302020-06-11
00845225003128QuickClear Thrombectomy SystemAC8SH085AC8SH0852020-06-11
00845225003142QuickClear Thrombectomy SystemAC10SH085AC10SH0852020-06-11
00845225003180Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy CatheterPD24130PD241302021-10-26
00845225003197Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy SystemPD24130KPD24130K2021-10-26
00845225002985Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy CatheterPD22130PD221302019-03-07
00845225002992Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy SystemPD22130K PD22130K2019-03-07
00845225003166Phoenix 1.5mm x 149cm 4F Atherectomy CatheterP15149P151492021-10-26
00845225003173Phoenix 1.5mm x 149cm 4F Atherectomy SystemP15149KP15149K2021-10-26
00845225002619Phoenix 1.8mm x 130cm 5F Atherectomy CatheterP18130P181302016-09-01
00845225002626Phoenix 2.2mm x 130cm 6F Atherectomy CatheterP22130P221302016-09-01
00845225002633Phoenix 2.4mm 7F Deflecting Atherectomy CatheterPD24127PD241272016-09-01
00845225002640Phoenix 1.8mm x 149cm 5F Atherectomy CatheterP18149P181492016-09-01
00845225002657Phoenix 2.2mm x 149cm 6F Atherectomy CatheterP22149P221492016-09-01
00845225002695Phoenix 1.8mm x 130cm 5F Atherectomy SystemP18130KP18130K2016-09-01
00845225002701Phoenix 2.2mm x 130cm 6F Atherectomy SystemP22130KP22130K2016-09-01
00845225002718Phoenix 2.4mm 7F Deflecting Atherectomy SystemPD24127KPD24127K2016-09-01
00845225002725Phoenix 1.8mm x 149cm 5F Atherectomy SystemP18149KP18149K2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10841156110505PRONTOTELEFLEX INCORPORATEDQEZ2026-03-30
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00851279008934pVasc Aspiration Catheter 70, 132 cmVesalioQEZ2026-03-26
00851279008941pVasc Aspiration Catheter 70, 140 cmVesalioQEZ2026-03-26
00860011713104FLOWRUNNER 14F Aspiration System, 80cmExpanse Medical, Inc.QEZ2026-01-12
00860011713111FLOWRUNNER 12F Aspiration System, 120cmExpanse Medical, Inc.QEZ2026-01-12
00860011713128FLOWRUNNER 12F Aspiration System, 80cmExpanse Medical, Inc.QEZ2026-01-12
00860011713142FLOWRUNNER 14F Aspiration System, 120cmExpanse Medical, Inc.QEZ2026-01-12
00860011713166FLOWRUNNER 12F Aspiration System, 100cmExpanse Medical, Inc.QEZ2026-01-12
00860011713180FLOWRUNNER 14F Aspiration System, 100cmExpanse Medical, Inc.QEZ2026-01-12
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