Identity
- Trade Name
- Map-iT FDA UDI
- Generic Name
- Intracardiac catheter-tip electrode FDA UDI
- Device Name
- Fixed, 4 electrode, MPA, 2mm electrode spacing FDA UDI
- Model / Reference
- 901421 FDA UDI
- Description
- Fixed, 4 electrode, MPA, 2mm electrode spacing FDA UDI
Identifiers
- Catalog Number
- 901421 FDA UDI
- Primary DI / UDI-DI
- 00818083010676 FDA UDI
- 510(k) Number
- K160390 FDA UDI
- FDA Product Code
- DRF FDA UDI
- GMDN Term
- Intracardiac catheter-tip electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 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
Dimensions & Sizes
- Size
- Catheter Gauge — 5 French FDA UDILength — 120 Centimeter FDA UDI
Category: Intracardiac catheter-tip electrode
Map-iT by Access Point Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracardiac catheter-tip electrode.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
Cleared under the same submission
K160390 also covers:
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, INC.
- Map-iT — ACCESS POINT TECHNOLOGIES, 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
- Access Point Technologies, Inc.
Sources (1)
- FDA UDI d04d733d-19ca-4db3-a785-be056a7b67d2 36 fields · synced Jun 6, 2026