PVS 2000 SYNCHRO2 GUIDEWIRE

Wire, Guide, Catheter

BOSTON SCIENTIFIC - PRECISION VASCULAR

The following data is part of a premarket notification filed by Boston Scientific - Precision Vascular with the FDA for Pvs 2000 Synchro2 Guidewire.

Pre-market Notification Details

Device IDK053268
510k NumberK053268
Device Name:PVS 2000 SYNCHRO2 GUIDEWIRE
ClassificationWire, Guide, Catheter
Applicant BOSTON SCIENTIFIC - PRECISION VASCULAR 2405 WEST ORTON CIR. West Valley City,  UT  84119
ContactRick Gaykowski
CorrespondentRick Gaykowski
BOSTON SCIENTIFIC - PRECISION VASCULAR 2405 WEST ORTON CIR. West Valley City,  UT  84119
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-23
Decision Date2006-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04546540688798 K053268 000
04546540688781 K053268 000
04546540688774 K053268 000
04546540688767 K053268 000
04546540688750 K053268 000
04546540688743 K053268 000
04546540688736 K053268 000
04546540688729 K053268 000

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