Identity
- Trade Name
- Amplatz FDA UDI
- Generic Name
- Non-vascular catheter introduction set FDA UDI
- Device Name
- Amplatz Radiopaque TFE Sheath FDA UDI
- Model / Reference
- G57472 FDA UDI
- Description
- Amplatz Radiopaque TFE Sheath FDA UDI
Identifiers
- Catalog Number
- VS-300016-ARI-01 FDA UDI
- Primary DI / UDI-DI
- 00827002574724 FDA UDI
- 510(k) Number
- K172527 FDA UDI
- FDA Product Code
- LJE FDA UDI
- GMDN Term
- Non-vascular catheter introduction set FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Category: Non-vascular catheter introduction set
Amplatz by Cook Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-vascular catheter introduction set.
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- Inrad — Inrad · Class II
- MAK-NV™ — Merit Medical Systems, Inc. · Class I
- Operative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle — FLEXBAR MACHINE CORP. · Class I
- MAK-NV™ — Merit Medical Systems, Inc. · Class I
Cleared under the same submission
K172527 also covers:
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Amplatz — COOK INCORPORATED
- Cook — COOK INCORPORATED
- Cook — COOK 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 U | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 7f6c336d-117f-41be-afd9-039272e666c3 37 fields · synced Jun 8, 2026