Duns Number:849716605
Device Description: STEERABLE GUIDE CATHETER, MITRACLIP US
Catalog Number
SGC0101
Brand Name
MITRACLIP
Version/Model Number
SGC0101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2018
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
-
Product Code
DRA
Product Code Name
CATHETER, STEERABLE
Public Device Record Key
afb15969-660e-451d-beab-60b02125c038
Public Version Date
May 31, 2018
Public Version Number
3
DI Record Publish Date
November 26, 2014
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. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 1 |