Duns Number:002586317
Device Description: THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retr THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor and brain access devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spine. It has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel or port that are secured by a spring-loaded latch. There is also an Alignment Clip (AC) included separately in the packaging that may be optionally attached to aid in the centering of third-party instrumentation, specifically navigational and image guided system (“IGS”) pointers or probes (“pointer”). Each VBAS device allows for the gentle retraction of tissue, visualization of the surgical site and for the manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
Catalog Number
-
Brand Name
Vycor Viewsite Brain Access System with Alignment Clip
Version/Model Number
TC171105AC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K202694
Product Code
GZT
Product Code Name
Retractor, Self-Retaining, For Neurosurgery
Public Device Record Key
ffc87b92-0842-4180-b300-25dd0cd2b6e5
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
May 19, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 26 |