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510(k) K083784

Device
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
Applicant
VASCULAR SOLUTIONS, INC.
510(k) number
K083784
Product code
DXE  
Decision
Substantially Equivalent (SESE)
Decision date
2009-03-30
Date received
2008-12-19
Regulation
870.5150
Classification name
Catheter, Embolectomy
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHARMAINE SUTTON
Address
6464 Sycamore Ct. Minneapolis MN US 55369 55369

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC2024-08-28
K241330Fogarty Fortis Arterial Embolectomy CatheterEdwards Lifesciences2024-07-02
K233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLC2024-05-22
K233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards Lifesciences2024-05-22
K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards Lifesciences2024-05-20
K213771Merlin Aspiration SystemMivi Neurovascular, Inc.2022-01-27
K202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation2021-09-07
K193379Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeEdwards Lifesciences, LLC2020-06-12
K163031Bunegin-Albin Air Aspiration SetCook Incorporated2017-07-27
K163353Needle's Eye Snare Retrieval Set - 54cmCook Incorporated2017-07-11
K152335Export Advance Aspiration CatheterMedtronic, Inc.2015-09-18
K100840EMBO PLUS EMBOLECTOMY CATHETERHotspur Technologies2010-07-12
K100842PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CMHotspur Technologies2010-07-12
K081573MEDTRONIC EXPORT AP CATHETERMedtronic Vascular2008-06-27
K022145OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302LeMaitre Vascular, Inc.2003-01-14

Legacy Summary#

summary

FDA Review#

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