← Back to catalogue

Therapy™

FDA UDI

Class III (US FDA UDI)

by Irvine Biomedical, Inc.

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-83367 FDA UDI
Description
Ablation Catheter FDA UDI

Identifiers

Catalog Number
IBI-83367 FDA UDI
Primary DI / UDI-DI
05414734306942 FDA UDI
PMA Number
P040014 FDA UDI
FDA Product Code
LPB 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
MRI Safety
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

P040014 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Irvine Biomedical, Inc.

Sources (1)

  • FDA UDI d2e3acb6-d7a2-4def-8d44-fd545a296cb3 39 fields · synced Jun 1, 2026