PVS 1300 NEURO GUIDE WIRE

Wire, Guide, Catheter

PRECISION VASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Precision Vascular Systems, Inc. with the FDA for Pvs 1300 Neuro Guide Wire.

Pre-market Notification Details

Device IDK002907
510k NumberK002907
Device Name:PVS 1300 NEURO GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant PRECISION VASCULAR SYSTEMS, INC. 360 WAKARA WAY Salt Lake City,  UT  84108
ContactJohn R Ragazzo
CorrespondentJohn R Ragazzo
PRECISION VASCULAR SYSTEMS, INC. 360 WAKARA WAY Salt Lake City,  UT  84108
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-18
Decision Date2001-03-08

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