FDA.reportPublic FDA data

QuickClear Aspiration Pump

Primary DI
00845225003012
Brand
QuickClear Aspiration Pump
Company
Volcano Atheromed, Inc.
Model
P3223
Catalog number
P3223
Published
2020-06-11
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
DXECatheter, Embolectomy
QEZAspiration Thrombectomy Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2
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
00845225003012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225003012008452250030128452250030120845225003012

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.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225003104QuickClear Thrombectomy SystemAC8ST085AC8ST0852022-01-19
00845225003005QuickClear Aspiration PumpP3223ASPP3223ASP2020-06-11
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
Primary DIBrandCompanyProduct codePublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00763000998011Liberant™MEDTRONIC, INC.QEZ2026-05-09
08886483504455Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504486Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504516Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
10841156110505PRONTOTELEFLEX INCORPORATEDQEZ2026-03-30
00851279008910pVasc Aspiration Catheter 70, 115 cmVesalioQEZ2026-03-26
00851279008927pVasc Aspiration Catheter 70, 125 cmVesalioQEZ2026-03-26
00851279008934pVasc Aspiration Catheter 70, 132 cmVesalioQEZ2026-03-26
00851279008941pVasc Aspiration Catheter 70, 140 cmVesalioQEZ2026-03-26
10841156110512PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
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
B090P110900VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P11090F0VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P110901VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P11090F1VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
10841156110482PRONTOTELEFLEX INCORPORATEDQEZ2025-09-17
20841156110489PRONTOTELEFLEX INCORPORATEDQEZ2025-09-17
10841156110475PRONTOTELEFLEX INCORPORATEDQEZ2025-08-25
20841156110472PRONTOTELEFLEX INCORPORATEDQEZ2025-08-25
10841156110499PRONTOTELEFLEX INCORPORATEDQEZ2025-03-18
20841156110496PRONTOTELEFLEX INCORPORATEDQEZ2025-03-18
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.DXE2024-12-20