VASCUTEK GELSOFT PLUS VASCULAR GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

VASCUTEK LTD.

The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Vascutek Gelsoft Plus Vascular Graft.

Pre-market Notification Details

Device IDK955230
510k NumberK955230
Device Name:VASCUTEK GELSOFT PLUS VASCULAR GRAFT
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant VASCUTEK LTD. 1300 EAST ANDERSON LN. Austin,  TX  78752
ContactTeena M Augostino
CorrespondentTeena M Augostino
VASCUTEK LTD. 1300 EAST ANDERSON LN. Austin,  TX  78752
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-14
Decision Date1996-02-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05037881000480 K955230 000
05037881115481 K955230 000
05037881115474 K955230 000
05037881115467 K955230 000
05037881115450 K955230 000
05037881115443 K955230 000
05037881115436 K955230 000
05037881115429 K955230 000

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