FDA.reportPublic FDA data

PRONTO

Primary DI
10841156110505
Brand
PRONTO
Company
TELEFLEX INCORPORATED
Model
IPN927370
Catalog number
5015
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841156110502PackageGS11In Commercial Distribution
10841156110505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084115611050220841156110502
1084115611050510841156110505

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.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000998011Liberant™MEDTRONIC, INC.QEZ2026-05-09
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
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
15051684025966AlphaVacAngiodynamics, Inc.QEZ2024-09-27
15051684025959AlphaVacAngiodynamics, Inc.QEZ2024-09-27
15051684025942AlphaVacAngiodynamics, Inc.QEZ2024-09-27
00813132029869QuickClear Aspiration PumpPhilips Image Guided Therapy CorporationQEZ2023-06-09
B090ASP10130Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10210Control 11F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10330Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10360Control 11F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10131Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03