TRU-TRAC TORQUE GUIDEWIRE

Wire, Guide, Catheter

N-S MEDICAL PRODUCTS

The following data is part of a premarket notification filed by N-s Medical Products with the FDA for Tru-trac Torque Guidewire.

Pre-market Notification Details

Device IDK880288
510k NumberK880288
Device Name:TRU-TRAC TORQUE GUIDEWIRE
ClassificationWire, Guide, Catheter
Applicant N-S MEDICAL PRODUCTS 4435 S.W. 35TH TERRACE SUITE 360 Gainesville,  FL  32608
ContactKeith L Stahl
CorrespondentKeith L Stahl
N-S MEDICAL PRODUCTS 4435 S.W. 35TH TERRACE SUITE 360 Gainesville,  FL  32608
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-25
Decision Date1988-09-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886333003505 K880288 000
20886333003499 K880288 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.