Identity
- Trade Name
- Therapy™ FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system catheter FDA UDI
- Device Name
- Ablation Catheter FDA UDI
- Model / Reference
- IBI-84308 FDA UDI
- Description
- Ablation Catheter FDA UDI
Identifiers
- Catalog Number
- IBI-84308 FDA UDI
- Primary DI / UDI-DI
- 05414734308564 FDA UDI
- PMA Number
- P060019 FDA UDI
- FDA Product Code
- OAD 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 7 French FDA UDI
Category: Cardiac radio-frequency ablation system catheter
Therapy™ by Irvine Biomedical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac radio-frequency ablation system catheter.
- INTELLANAV STABLEPOINT™ — Boston Scientific · Class III
- Blazer® II XP — Boston Scientific · Class III
- Celsius — Biosense Webster Inc · Class II
- ThermoCool SF — Biosense Webster Inc · Class III
- EZ Steer DS — Biosense Webster Inc · Class III
- Livewire™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION · Class III
- EZ Steer — Biosense Webster Inc · Class III
- NaviStar DS — Biosense Webster Inc · Class III
Cleared under the same submission
P060019 also covers:
- Cool Point™ — IRVINE BIOMEDICAL, INC.
- Cool Point™ — IRVINE BIOMEDICAL, INC.
- Cool Point™ — IRVINE BIOMEDICAL, INC.
- SJM™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, 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
- Irvine Biomedical, Inc.
Sources (1)
- FDA UDI 6509099f-e4a2-440e-87aa-01a1890480c7 38 fields · synced May 30, 2026