FDA-Device2021-08-25Class II
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
W L Gore & Associates, Inc.
Hazard
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
Sold states
US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia
Affected count
N/A
Manufactured in
3750 W Kiltie Ln, N/A, Flagstaff, AZ, United States
Products
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2293-2021Don't want to check this manually?
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