Duns Number:608625823
Device Description: The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).
Catalog Number
R-014R
Brand Name
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
Version/Model Number
R-014R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 24, 2024
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
K200195
Product Code
OBJ
Product Code Name
Catheter, Ultrasound, Intravascular
Public Device Record Key
924596c4-ae42-496b-be2f-3808297b848b
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 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 |
|---|---|---|
| 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 |