FDA.reportPublic FDA data

510(k) K102101

Device
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
Applicant
Surgivision, Inc.
510(k) number
K102101
Product code
HCD
Decision
Substantially Equivalent (SESE)
Decision date
2011-01-26
Date received
2010-07-27
Regulation
882.4060
Classification name
Cannula, Ventricular
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EDWARD WADDELL
Address
5 Musick Irvine CA US 92618 92618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HCD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150660Alcyone MEMS Cannula (AMC) SystemAlcyone Lifesciences, Inc.2015-04-16
K920088CAMINO VENTRICULAR NEEDLECamino Laboratories, Inc.1992-05-01