Navistar DS Electrophysiology Catheter

FDA PMA

Class III (US FDA PMA)

PMA P010068

by Biosense Webster Inc

Identity

Trade Name: NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER FDA PMA
Generic Name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter FDA PMA

Identifiers

PMA Number: P010068 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 Navistar DS Electrophysiology Catheter is a percutaneous cardiac ablation device designed for catheter-based cardiac electrophysiological mapping, including stimulation and recording. When used in conjunction with the CARTO EP navigation system, the catheter provides essential location information during cardiac procedures.

This device is indicated for use with the Stockert 70 generator for the treatment of type I atrial flutter in patients aged 18 or older. It has received FDA PMA authorization and meets MDD regulatory requirements for clinical use.

Frequently asked questions

What is the primary use of the Navistar DS catheter?

The Navistar DS catheter is indicated for catheter-based cardiac electrophysiological mapping, which involves stimulation and recording, as well as for the treatment of type I atrial flutter in patients 18 years of age or older.

Does the Navistar DS catheter work with navigation systems?

Yes, the Navistar DS catheter is designed to provide location information when used in combination with the CARTO EP navigation system.

What equipment is required to use this catheter for ablation?

The Navistar DS catheter is intended for use with the Stockert 70 generator (model S7001 with software version 001/033) and its associated accessories to perform cardiac ablation procedures.

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. Sources consulted: CARTO™ NAVISTAR™ Catheter | Biosense Webster, Premarket Approval (PMA) - FDA, [PDF] CATALOGUE 2018 - Electrophysiology, NAVISTAR DS Navigation and Ablation Catheters - PDF Catalogs, Medical device - MSA

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Pending data

MDD

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	European Union	MDD	—	Class III	Pending data
FDA PMA	United States	FDA_PMA	P010068	Class III	Active

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Manufacturer

Manufacturer: Biosense Webster Inc
FDA Applicant: Biosense Webster, Inc.

Sources (1)

FDA PMA P010068 24 fields · synced Sep 18, 2026