FDA.reportPublic FDA data

Pronto® LP extraction catheter

Primary DI
M20650150
Brand
Pronto® LP extraction catheter
Company
Vascular Solutions, Inc.
Model
5015
Device description
The Pronto LP catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system.
Published
2016-09-05
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20650150PrimaryHIBCC0

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
Catheter Gauge5French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-240-6001customerservice@vasc.com

Regulatory Flags#

DUNS number
008999906
Device count
1
Lot or batch
true
Expiration date on label
true

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M206780600SmartNeedle® vascular access system780602016-09-06
M206780300SmartNeedle® vascular access system780302016-09-05
M206780400SmartNeedle® vascular access system780402016-09-06
M206720000SmartNeedle® monitor720002016-09-23
M20631010Thrombix® Hemostasis Patch topical hemostat31012016-09-15
M20630100D-Stat® 2 Dry topical hemostat30102016-09-15
M20681500Teirstein Edge™ device organizer81502016-09-05
M20681510Angio Assist™ docking station81512016-09-05
M20673710Axis™ guidewire73712016-09-05
M20673720Axis™ guidewire73722016-09-05
M20674720VSI Tru-Torque™ guidewire74722016-09-05
M20674730VSI Tru-Torque™ guidewire74732016-09-05
M20674790Amplatz SST™ guidewire74792016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483504455Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504486Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504516Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
10841156110512PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.DXE2024-12-20
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
08886483507524Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2023-10-31
00860010378007ICHORICHOR VASCULAR, INC.DXE2023-10-13
10801902196603ARROWTELEFLEX INCORPORATEDDXE2022-11-15
20801902196600ARROWTELEFLEX INCORPORATEDDXE2022-11-15
10801902194043ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194050ARROWTELEFLEX INCORPORATEDDXE2022-11-08
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10801902196610ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194040ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194057ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194064ARROWTELEFLEX INCORPORATEDDXE2022-11-08