Duns Number:134139174
Device Description: FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 40CM
Catalog Number
120403FP
Brand Name
FOGARTY
Version/Model Number
120403FP
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
K193379,K193379
Product Code
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
7a5ce147-4339-4a47-aa43-11ea405e56b2
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
September 15, 2020
Package DI Number
50690103205089
Quantity per Package
5
Contains DI Package
00690103205084
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHIPPER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |