FDA.report

510(k) K922410

Device
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL
Applicant
SCIMED LIFE SYSTEMS, INC.
510(k) number
K922410
Product code
DQX  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-23
Date received
1992-05-21
Regulation
870.1330
Classification name
Wire, Guide, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MERCEDES P BAYANI
Address
6655 Wedgwood Rd. Maple Grove MN US 55369 55369

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

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FDA Review

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