Identity
- Trade Name
- Micro Access FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Echogenic Needle FDA UDI
- Model / Reference
- 06508601 FDA UDI
- Description
- Echogenic Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- H787065086010 FDA UDI
- 510(k) Number
- K051655 FDA UDI
- FDA Product Code
- DQR FDA UDIDRC FDA UDIDYB FDA UDIDQX FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1300 FDA UDI870.1390 FDA UDI870.1340 FDA UDI870.1330 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
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
Category: Vascular catheter introduction set, nonimplantable
Micro Access by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular catheter introduction set, nonimplantable.
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- ARROW — TELEFLEX INCORPORATED · Class II
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Cleared under the same submission
K051655 also covers:
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
- AngioDynamics — ANGIODYNAMICS, INC
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 |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc.
Sources (1)
- FDA UDI db767ccb-89a1-4086-a64e-2a00fa55fc22 36 fields · synced Jun 8, 2026