FDA.report

510(k) K884183

Device
BURRON TEFLON-COATED GUIDEWIRE
Applicant
BURRON MEDICAL, INC.
510(k) number
K884183
Product code
DQX  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-03
Date received
1988-10-04
Regulation
870.1330
Classification name
Wire, Guide, Catheter
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
PEGGY KEIFFER
Address
824 Twelfth Ave. Bethlehem PA US 18018 18018

FDA Registration Numbers

Source Documents

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

Legacy Summary

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FDA Review

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