Duns Number:482661753
Device Description: REVIVE PV peripheral vascular thrombectomy device 4.5mm x 22mm 6 mm 205 cm 0.014 Inch Peri REVIVE PV peripheral vascular thrombectomy device 4.5mm x 22mm 6 mm 205 cm 0.014 Inch Peripheral Vascular Thrombectomy Device Recommended Microcatheter .027 Inch Contents: 1 Thrombectomy Device, 1 Introducer
Catalog Number
PV21452200
Brand Name
REVIVE
Version/Model Number
PV21452200
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
K132281
Product Code
DXE
Product Code Name
CATHETER, EMBOLECTOMY
Public Device Record Key
3d4842f0-cf1a-4a04-a5ce-1989cc75a503
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
June 30, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |