Identity
- Trade Name
- EP Recording Catheter FDA UDI
- Generic Name
- Cardiac mapping/endocardial-injection catheter FDA UDI
- Device Name
- EP Recording Catheter 14 pole, fixed curve FDA UDI
- Model / Reference
- CF-D7-AAA-NSDA FDA UDI
- Description
- EP Recording Catheter 14 pole, fixed curve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331011852 FDA UDI
- 510(k) Number
- K021421 FDA UDI
- FDA Product Code
- DRF FDA UDI
- GMDN Term
- Cardiac mapping/endocardial-injection catheter 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
No
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: Cardiac mapping/endocardial-injection catheter
EP Recording Catheter by Tz Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac mapping/endocardial-injection catheter.
- 14 Pole Catheter Cable — Tz Medical, Inc. · Class II
Cleared under the same submission
K021421 also covers:
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
- Tz Medical, Inc.
Sources (1)
- FDA UDI f0b3435b-05f1-435c-b4e1-3e14e6cb87d0 34 fields · synced May 29, 2026