Identity
- Trade Name
- AngioTouch® Kit FDA UDI
- Generic Name
- Contrast medium injection system hand controller kit FDA UDI
- Device Name
- Model AT P65, p/n 701677-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing FDA UDI
- Model / Reference
- 014645 FDA UDI
- Description
- Model AT P65, p/n 701677-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841716102001 FDA UDI
- 510(k) Number
- K171646 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Contrast medium injection system hand controller kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
Yes
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: Contrast medium injection system hand controller kit
AngioTouch® Kit by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171646 also covers:
- ACIST CVi® Contrast Delivery System — ACIST Medical Systems, Inc.
- ACIST CVi® Contrast Delivery System — ACIST Medical Systems, Inc.
- ACIST CVi® Contrast Delivery System Control Panel — ACIST Medical Systems, Inc.
- ACIST CVi® Contrast Delivery System Injector Head — ACIST Medical Systems, Inc.
- ACIST CVi® Contrast Delivery System Injector Head — ACIST Medical Systems, Inc.
- ACIST CVi® Contrast Delivery System Power Supply — ACIST Medical Systems, Inc.
- AngioTouch® Kit — ACIST Medical Systems, Inc.
- BT2000 Automated Manifold Kit — ACIST Medical Systems, 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
- ACIST Medical Systems, Inc.
Sources (1)
- FDA UDI 5e26410d-d4b2-48af-9c4c-9d1385b95ea3 34 fields · synced Jun 8, 2026