Fogarty 120803FSP

GUDID 50690103205249

Fogarty Embolectomy Catheter

Edwards Lifesciences LLC

Thrombectomy balloon catheter
Primary Device ID50690103205249
NIH Device Record Keye36971c7-eba9-4231-89bf-c79a8a0a8d61
Commercial Distribution StatusIn Commercial Distribution
Brand NameFogarty
Version Model Number120803FSP
Catalog Number120803FSP
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103205244 [Primary]
GS150690103205249 [Package]
Contains: 00690103205244
Package: SHIPPER [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-23
Device Publish Date2020-09-15

On-Brand Devices [Fogarty]

00690103177657FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 3F 120CM
00690103176186ARTERIAL EMBOLECTOMY CATHETER WITH GATE VALVE 2F 45CM
00690103163223FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER 4F 80CM
00690103043785FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER
00690103043754FOGARTY OCCLUSION CATHETER 8/22F 80CM
00690103043747FOGARTY OCCLUSION CATHETER 8/14F 80CM
00690103043730FOGARTY OCCLUSION CATHETER 5F 40CM
00690103043723FOGARTY OCCLUSION CATHETER 4F 40CM
00690103043716FOGARTY OCCLUSION CATHETER 3F 40CM
00690103043662FOGARTY BILIARY BALLOON PROBE 5F 40CM
00690103043655FOGARTY BILIARY BALLOON PROBE 6F 23CM
00690103043648FOGARTY BILIARY BALLOON PROBE 5F 23CM
00690103043631FOGARTY VENOUS THROMBECTOMY CATHETER 8F 80CM
00690103043624FOGARTY VENOUS THROMBECTOMY CATHETER 8/10F 80CM
00690103043617FOGARTY VENOUS THROMBECTOMY CATHETER 6F 80CM
00690103043600FOGARTY IRRIGATION CATHETER 6FR 80CM
00690103043594FOGARTY IRRIGATION CATHETER 4F, 80CM
00690103043587FOGARTY IRRIGATION CATHETER 10F, 23CM
00690103043570FOGARTY GRAFT THROMBECTOMY CATHETER 6F 50CM
00690103043563FOGARTY GRAFT THROMBECTOMY CATHETER, 5F 50CM
00690103043556FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 7F 80CM
00690103043549FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 6F 80CM
00690103043532FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 5.5F 80CM
00690103043518FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 4F 80CM
00690103043501FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 3F 80CM
00690103043495FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 6F 40CM
00690103043488FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 5.5F 40CM
00690103043464FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER, 4F 40CM
00690103043457FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 3F 40CM
00690103043440FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 100CM
00690103043433FOGARTY ARTERIAL EMBOLECTOMY CATHETER 7F 80CM
00690103043426FOGARTY ARTERIAL EMBOLECTOMY CATHETER 6F 80CM
00690103043419FOGARTY ARTERIAL EMBOLECTOMY CATHETER 5F 80CM
00690103043402FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 80CM
00690103043396FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 80CM
00690103043389CATH,FOGARTY ART EMB 2FR 60CM FLAT PACK W/NAT RUB LATEX,STER
00690103043372FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 40CM
00690103043365FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 40CM
00690103043341FOGARTY ARTERIAL EMBOLECTOMY CATHETER 7F 80CM
00690103043327FOGARTY ARTERIAL EMBOLECTOMY CATHETER 6F 80CM
00690103043310FOGARTY ARTERIAL EMBOLECTOMY CATHETER 5F 80CM
00690103043303FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 80CM
00690103043297FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 80CM
00690103043280FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 80CM
00690103043273FOGARTY ARTERIAL EMBOLECTOMY CATHETER 2F 60CM
00690103043266FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 40CM
00690103043259FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 40CM
00690103043242FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 40CM
50690103205133FOGARTY BILIARY BALLOON PROBE 5F 40CM
50690103205126FOGARTY BILIARY BALLOON PROBE 6F 23CM

Trademark Results [Fogarty]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FOGARTY
FOGARTY
87175386 not registered Dead/Abandoned
Dunelm (Soft Furnishings) Limited
2016-09-19
FOGARTY
FOGARTY
85218443 4024207 Dead/Cancelled
Fogarty Holdings Limited
2011-01-14
FOGARTY
FOGARTY
78152469 2865825 Dead/Cancelled
Fogarty Holdings Limited
2002-08-08
FOGARTY
FOGARTY
73795379 not registered Dead/Abandoned
COLOROLL HOME FURNISHINGS LIMITED
1989-04-24
FOGARTY
FOGARTY
73200045 1172120 Live/Registered
American Hospital Supply Corporation
1979-01-15
FOGARTY
FOGARTY
72274724 0859124 Dead/Expired
EDWARDS LABORATORIES, INC.
1967-06-26

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