FDA.report

510(k) K200950

Device
Ventricular Catheter
Applicant
Aesculap, Inc.
510(k) number
K200950
Product code
JXG  
Decision
Substantially Equivalent (SESE)
Decision date
2020-05-08
Date received
2020-04-09
Regulation
882.5550
Classification name
Shunt, Central Nervous System And Components
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Kathy A. Racosky
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers

Source Documents

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

Legacy Summary

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FDA Review

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