Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, single-use FDA UDI
- Device Name
- Sterile Covers for use with VPS-G4C FDA UDI
- Model / Reference
- IPN035983 FDA UDI
- Description
- Sterile Covers for use with VPS-G4C FDA UDI
Identifiers
- Catalog Number
- VPS-G4SC FDA UDI
- Primary DI / UDI-DI
- 00801902081490 FDA UDI
- 510(k) Number
- K050322 FDA UDI
- FDA Product Code
- KKK FDA UDI
- GMDN Term
- Intravascular ultrasound imaging catheter, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Commercial Distribution
- 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
Yes
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
Category: Intravascular ultrasound imaging catheter, single-use
Arrow by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular ultrasound imaging catheter, single-use.
- SLT IVUS Support Crossing Catheter — Provisio Medical, Inc. · Class II
- OptiCross™ HD — Boston Scientific · Class II
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- VeriSight Intracardiac Echocariography Catheter — Philips Image Guided Therapy Corporation · Class II
- ACIST Kodama® Coronary Imaging Catheter — ACIST Medical Systems, Inc. · Class II
- Novasight Hybrid™ Catheter PIM Bag — Conavi Medical Inc · Class II
- OptiCross™ 6 — Boston Scientific · Class II
- OptiCross™ HD — Boston Scientific · Class II
Cleared under the same submission
K050322 also covers:
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 5447f0e5-a3cd-40c3-86bd-bc55b61a6322 36 fields · synced Jun 8, 2026