RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715— 510(k) K063836

Substantially Equivalent

Medtronic Neurosurgery

FDA 510(k) clearance K063836 for RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715, Substantially Equivalent on 2007-08-16. Applicant: Medtronic Neurosurgery.

Clearance details

Applicant
Medtronic Neurosurgery
Product code
Code JXG
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Goleta, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JXG

product code JXG
Death
76
Injury
5,632
Malfunction
2,230
Other
4
Total
7,942

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.