FOGARTY 620404F

GUDID 00690103043723

FOGARTY OCCLUSION CATHETER 4F 40CM

Edwards Lifesciences LLC

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00690103043723
• NIH Device Record Key: 264a5235-15b5-4477-8416-bd27d694d87c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOGARTY
• Version Model Number: 620404F
• Catalog Number: 620404F
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103043723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093911

FDA Product Code

• MJN: Catheter, intravascular occluding, temporary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-09-03

On-Brand Devices [FOGARTY]

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