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Bi-Directional Celsius Fltr Catheters (d-1359-Xx-S)

FDA PMA

Class III (US FDA PMA)

PMA P950005

by Biosense Webster Inc

Identity

Trade Name
WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER FDA PMA
Generic Name
Cardiac ablation percutaneous catheter FDA PMA

Identifiers

PMA Number
P950005 FDA PMA
FDA Product Code
LPB FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The Bidirectional Celsius Fltr Catheters (D-1359-XX-S) are deflectable-tip cardiac ablation percutaneous catheters designed for electrophysiological mapping and radiofrequency ablation procedures. These catheters feature six curve types (A, B, C, D, E, and F), a 4mm tip electrode (large and grooved), and are available with either a Redel 10-pin connector (temperature sensing) or a Nexus plug (non-temperature-sensing). Their electrode spacing follows a standard 2-5-2 pattern (center-to-center measurement).

These catheters are intended for use in cardiac electrophysiology labs, supplied sterile for single-use, and are regulated under FDA Premarket Approval (PMA P950005). They are designed for interruption of accessory atrioventricular conduction pathways, treatment of AV nodal re-entrant tachycardia, and creation of complete AV nodal block in select patients. The catheters require compatibility with a compatible RF generator for therapeutic use.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Biosense Webster Inc
FDA Applicant
Biosense Webster, Inc.

Sources (1)

  • FDA PMA P950005 24 fields · synced Sep 18, 2026