Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, implantable FDA UDI
- Device Name
- Cannon Catheter(R) II Plus Replacement Hub Set Fits 15 Fr. x 19 cm Models FDA UDI
- Model / Reference
- IPN032943 FDA UDI
- Description
- Cannon Catheter(R) II Plus Replacement Hub Set Fits 15 Fr. x 19 cm Models FDA UDI
Identifiers
- Catalog Number
- CAR-02400 FDA UDI
- Primary DI / UDI-DI
- 00801902031563 FDA UDI
- 510(k) Number
- K020430 FDA UDI
- FDA Product Code
- NFK FDA UDI
- GMDN Term
- Double-lumen haemodialysis catheter, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 15 French FDA UDILength — 19 Centimeter FDA UDI
Category: Double-lumen haemodialysis catheter, implantable
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Double-lumen haemodialysis catheter, implantable.
- EvenMore — ANGIODYNAMICS, INC · Class II
- Amecath Y split catheter — Ameco Medical Industries · Class II
- Palindrome — Mozarc Medical US LLC · Class II
- HemoSplit Long-Term Hemodialysis Catheter — Bard Access Systems, Inc. · Class II
- Palindrome — Mozarc Medical US LLC · Class II
- HEMO-FLOW® — MEDICAL COMPONENTS INC · Class II
- DuraFlow™2 — Merit Medical Systems, Inc. · Class II
- HemoSplit Long-Term Hemodialysis Catheter — Bard Access Systems, Inc. · Class II
Cleared under the same submission
K020430 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
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
- Teleflex Incorporated
Sources (1)
- FDA UDI edcc2558-3407-4f12-955d-a3305736f4bf 37 fields · synced May 31, 2026