← Back to catalogue
NES Reprocessed Visions PV .035 Digital IVUS Catheter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- NES Reprocessed Visions PV .035 Digital IVUS Catheter FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
- Device Name
- The device is the Philips Vision PV .035 Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES). FDA UDI
- Model / Reference
- R-88901 FDA UDI
- Description
- The device is the Philips Vision PV .035 Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES). FDA UDI
Identifiers
- Catalog Number
- R-88901 FDA UDI
- Primary DI / UDI-DI
- R88901 FDA UDI
- 510(k) Number
- K181126 FDA UDI
- FDA Product Code
- OWQ FDA UDI
- GMDN Term
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 90 Centimeter FDA UDILumen/Inner Diameter — .035 Inch FDA UDI
NES Reprocessed Visions PV .035 Digital IVUS Catheter by Northeast Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K181126 also covers:
- NES Reprocessed .035 Stryker Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed .035 Stryker Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed Visions PV .035 Digital IVUS Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed Visions PV .035 Digital IVUS Catheter — NORTHEAST SCIENTIFIC, INC.
- Philips Healthcare — Stryker Sustainability Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Northeast Scientific, Inc.
Sources (1)
- FDA UDI 7ae4240a-cef4-4783-91df-a45ceabac990 38 fields · synced Jun 8, 2026