Duns Number:608625823
Device Description: The device is the Philips Vision PV .035 Digital IVUS catheter that is reprocessed by Nort The device is the Philips Vision PV .035 Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).
Catalog Number
R-88901
Brand Name
NES Reprocessed Visions PV .035 Digital IVUS Catheter
Version/Model Number
R-88901
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 21, 2039
Issuing Agency
In HIBCC
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
K181126
Product Code
OWQ
Product Code Name
Reprocessed Intravascular Ultrasound Catheter
Public Device Record Key
7ae4240a-cef4-4783-91df-a45ceabac990
Public Version Date
June 10, 2021
Public Version Number
2
DI Record Publish Date
March 21, 2019
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |