FDA.report

510(k) K903606

Device
GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
Applicant
NORTH AMERICAN INSTRUMENT CORP.
510(k) number
K903606
Product code
LIT  
Decision
Substantially Equivalent (SESE)
Decision date
1990-09-27
Date received
1990-07-30
Regulation
870.1250
Classification name
Catheter, Angioplasty, Peripheral, Transluminal
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ROBERT E FRANKLIN
Address
Glens Falls NY US 12801 12801

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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Legacy Summary

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FDA Review

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