Duns Number:530923226
Device Description: Percutaneous Transluminal Angioplasty (PTA) Catheter
Catalog Number
-
Brand Name
Jade PTA Balloon Dilatation Catheter
Version/Model Number
582004012
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201794
Product Code
LIT
Product Code Name
Catheter, Angioplasty, Peripheral, Transluminal
Public Device Record Key
70361f45-dfa0-423a-99b4-873231d6c17d
Public Version Date
November 16, 2020
Public Version Number
1
DI Record Publish Date
November 06, 2020
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. | 1039 |
3 | A medical device with high risk that requires premarket approval | 24 |