VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES

Introducer, Catheter

THORATEC LABORATORIES CORP.

The following data is part of a premarket notification filed by Thoratec Laboratories Corp. with the FDA for Vascular Graft Tunneler-standard Curve, Mid Curve, Full Curve, Short Standard Curve, Vascular Graft Tunneler Accessories.

Pre-market Notification Details

Device IDK001926
510k NumberK001926
Device Name:VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES
ClassificationIntroducer, Catheter
Applicant THORATEC LABORATORIES CORP. 6035 STONERIDGE DR. Pleasanton,,  CA  94588
ContactDonald A Middlebrook
CorrespondentDonald A Middlebrook
THORATEC LABORATORIES CORP. 6035 STONERIDGE DR. Pleasanton,,  CA  94588
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-26
Decision Date2000-09-22

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