FDA.report

510(k) K163031

Device
Bunegin-Albin Air Aspiration Set
Applicant
COOK INCORPORATED
510(k) number
K163031
Product code
DXE  
Decision
Substantially Equivalent (SESE)
Decision date
2017-07-27
Date received
2016-10-31
Regulation
870.5150
Classification name
Catheter, Embolectomy
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
JOHNATHAN LIU
Address
750 Daniels Way Bloomington IN US 47404 47404

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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