THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR (UDI P060019)
Manufactured by Irvine Biomedical, Inc.
Device Regulatory Overview
The THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR (Model/Catalog Number: Unspecified) is a medical device manufactured by Irvine Biomedical, Inc.. This product is indexed under FDA Product Code / Category Classification OAD within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- OAD
- Device Name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Database Sync Date
- 2026-08-09 10:06:13
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR?
The registered manufacturer of record for THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR is Irvine Biomedical, Inc..
What is the Primary UDI-DI identifier for THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P060019.
What classification code is assigned to this device?
This device is registered under product classification code OAD.
Similar Classification Devices (OAD)
Other Devices by Irvine Biomedical, Inc.
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