FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR FDA PMA
- Generic Name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter FDA PMA
Identifiers
- PMA Number
- P110016 FDA PMA
- FDA Product Code
- OAD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE) is a catheter, percutaneous, cardiac ablation, for treatment of atrial flutter, designed to create endocardial lesions during cardiac ablation procedures. This device is intended for mapping, stimulation, and ablation in the treatment of typical atrial flutter, operating within a maximum power limit of 50 watts when used with compatible irrigation pumps and RF generators.
This catheter is supplied as a single-use, non-sterile device and requires sterilization prior to use. It is intended for use in electrophysiology laboratories and must be paired with the IBI 1500T-9 VI.6 Cardiac Ablation Generator and a compatible irrigation pump. The device is classified as Class III under FDA regulations and holds a PMA approval (P110016). No MRI safety information is specified in the provided data.
Frequently asked questions
What specific type of arrhythmia is the FlexAbility Ablation Catheter, Sensor Enabled, designed to treat, and how does it achieve this?
The FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE) is specifically designed for the treatment of **typical atrial flutter**, a type of irregular heartbeat originating in the atria. It achieves this by creating **endocardial lesions** during cardiac ablation procedures, which disrupt the abnormal electrical pathways causing the arrhythmia. The catheter operates within a maximum power limit of 50 watts when paired with compatible irrigation pumps and RF generators, enabling precise mapping, stimulation, and ablation.
Is the FlexAbility SE catheter intended for single-use or reusable, and what preparation is required before use?
The FlexAbility SE catheter is supplied as a **single-use, non-sterile device**, meaning it must be **sterilized prior to use** in an electrophysiology laboratory. Sterilization is a mandatory step before clinical application, as the device is not sterile out-of-the-box.
What equipment must the FlexAbility SE catheter be used with, and is there any compatibility requirement for power settings?
The FlexAbility SE catheter is designed to be used exclusively with the **IBI 1500T-9 VI.6 Cardiac Ablation Generator** and a **compatible irrigation pump**. It operates at a **maximum power limit of 50 watts**, ensuring safe and effective ablation during procedures for typical atrial flutter.
Does the FlexAbility SE catheter have any specific storage or handling instructions mentioned in the data?
The provided data does not explicitly detail storage instructions, but since the catheter is **non-sterile and requires sterilization before use**, it should be stored in a clean, dry environment to prevent contamination. Always follow manufacturer guidelines for sterilization and handling to ensure safety and functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110016 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P110016 24 fields · synced Oct 6, 2026