Identity
- Trade Name
- 14 Pole Catheter Cable FDA UDI
- Generic Name
- Cardiac mapping/endocardial-injection catheter FDA UDI
- Device Name
- 14 Pole Catheter Cable STERILE FDA UDI
- Model / Reference
- CS-H-14-10 FDA UDI
- Description
- 14 Pole Catheter Cable STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331017564 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
14 Pole Catheter Cable 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.
- EP Recording Catheter — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tz Medical, Inc.
Sources (1)
- FDA UDI 6083aed2-379c-427a-84e1-77f2377933fe 34 fields · synced Jun 8, 2026