FDA.report

510(k) K920823

Device
Welter Snare Retriever
Applicant
COOK, INC.
510(k) number
K920823
Product code
DXE
Decision
Substantially Equivalent (SESE)
Decision date
1993-03-04
Date received
1992-02-24
Regulation
870.5150
Classification name
Catheter, Embolectomy
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
APRIL LAVENDER
Address
925 S. Curry Pike P.O. Box 489 Bloomington IN US 47402 47402

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code DXE

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K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC2024-08-28
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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