Identity
- Trade Name
- Therapy™ FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system catheter FDA UDI
- Device Name
- Ablation Catheter FDA UDI
- Model / Reference
- Cool Path™ DUO SP FDA UDI
- Description
- Ablation Catheter FDA UDI
Identifiers
- Catalog Number
- A700454 FDA UDI
- Primary DI / UDI-DI
- 05415067004543 FDA UDI
- PMA Number
- P110016 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
- Not 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 7 French FDA UDI
Therapy™ by Irvine Biomedical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P110016 also covers:
- Cool Path™ — IRVINE BIOMEDICAL, INC.
- Cool Path™ — IRVINE BIOMEDICAL, INC.
- Cool Path™ — IRVINE BIOMEDICAL, INC.
- Cool Path™ — IRVINE BIOMEDICAL, INC.
- Safire™ Duo MediGuide Enabled™ — IRVINE BIOMEDICAL, INC.
- Safire™ Duo MediGuide Enabled™ — IRVINE BIOMEDICAL, INC.
- Safire™ Duo MediGuide Enabled™ — IRVINE BIOMEDICAL, INC.
- Safire™ Duo MediGuide Enabled™ — IRVINE BIOMEDICAL, INC.
- Ampere™ — ST. JUDE MEDICAL, INC.
- Ampere™ — ST. JUDE MEDICAL, INC.
- Ampere™ — ST. JUDE MEDICAL, INC.
- Ampere™ — 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
- Irvine Biomedical, Inc.
Sources (1)
- FDA UDI 62e9d235-af03-45a9-980d-1d47f9161383 39 fields · synced Jun 1, 2026