Identity
- Trade Name
- TactiFlex™ Sensor Enabled™ FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system catheter FDA UDI
- Device Name
- Ablation Catheter FDA UDI
- Model / Reference
- A-TFSE-F FDA UDI
- Description
- Ablation Catheter FDA UDI
Identifiers
- Catalog Number
- A-TFSE-F FDA UDI
- Primary DI / UDI-DI
- 05415067034670 FDA UDI
- PMA Number
- P220013 FDA UDI
- FDA Product Code
- OAE FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation system catheter FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 8.0000 French FDA UDILength — 115.0000 Centimeter FDA UDI
Category: Cardiac radio-frequency ablation system catheter
TactiFlex™ Sensor Enabled™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac radio-frequency ablation system catheter.
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Cleared under the same submission
P220013 also covers:
- TactiFlex™ Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- TactiFlex™ Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- TactiFlex™ Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- TactiFlex™ Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- TactiFlex™ Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- TactiFlex™ Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- TactiFlex™ Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- TactiSys™ Quartz Equipment — ST. JUDE MEDICAL, 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 III | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 520e2c98-a1db-4d60-a72e-54a64a7fe3dc 38 fields · synced Jun 6, 2026