FDA.report

510(k) K202049

Device
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
Applicant
Applied Medical Resources Corporation
510(k) number
K202049
Product code
DXE
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-07
Date received
2020-07-24
Regulation
870.5150
Classification name
Catheter, Embolectomy
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Andrew Powers Davis
Address
22872 Avenida Empresa Rancho Santa CA US 92688 92688

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code DXE

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
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
K020634MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETERAtrium Medical Corp.2002-05-08