Devices

Vascutek Gelsoft

  • Model / Serial
    Catalog Number 631508 Serial Numbers: 0001765391, 0001765392, 0001765393, 0001765394, 0001765395, 0001765396, 0001765397, 0001765398, 0001765399
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution in the states of: NC and CA.
  • Product Description
    Vascutek Gelsoft Vascular Graft (peripheral) || Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland***" || The Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed, woven polyester graft indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
  • 1 Event

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

Vascutek Gelsoft Plus
  • Model / Serial
    Model: , Affected: all Lots
  • Manufacturer
    Vascutek Ltd
Vascutek Gelsoft Plus
  • Model / Serial
    Model: , Affected: All Lots
  • Manufacturer
    Vascutek Ltd
VASCUTEK GELSOFT VASCULAR PROSTHESIS-AXILLO FEMORAL
  • Model / Serial
    Model Catalog: (Lot serial: ALL)
  • Product Description
    VASCUTEK GELSOFT VASCULAR PROSTHESIS - AXILLO FEMORAL;VASCUTEK GELSEAL VASCULAR PROSTHESIS - BIFURCATE;GELWEAVE SIENA COLLARED 4 BRANCH PLEXUS W/ RADIOPAQUE MARKERS;GELSOFT PLUS ERS AX-FEM [AXILLO-FEMORAL];SEALPTFE VASCULAR PROSTHESIS STD WALL STRAIGHT SE
  • Manufacturer
    LIVANOVA CANADA CORP.