QDOT MICRO Catheter, nGEN RF Generator, TX eco Cable, TX eco EXT Cable

FDA PMAFDA UDIEUDAMED

Class III (US FDA PMA)

PMA P210027Ref D135703Model SMARTABLATE System Interface Cable Stockert and CARTO XP Interface Cables CARTO 3 System Interface Cables Interface Cables CARTO 3 SYSTEM eco Interface Cable TX eco EXT Cable Interface Cables for Multi-Electrode Ablation Catheter and CELSIUS Catheter

by Biosense Webster Inc

Identity

Trade Name: TX eco EXT Cable EUDAMEDFDA UDI
QDOT MICRO System FDA PMA
Generic Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation FDA PMA
Electrical-only medical device connection cable, reusable FDA UDI
Device Name: SMARTABLATE System Interface Cable Stockert and CARTO XP Interface Cables CARTO 3 System Interface Cables Interface Cables CARTO 3 SYSTEM eco Interface Cable TX eco EXT Cable Interface Cables for Multi-Electrode Ablation Catheter and CELSIUS Catheter EUDAMED
TX eco EXT Cable FDA UDI
Model / Reference: D135703 EUDAMEDFDA UDI
SMARTABLATE System Interface Cable Stockert and CARTO XP Interface Cables CARTO 3 System Interface Cables Interface Cables CARTO 3 SYSTEM eco Interface Cable TX eco EXT Cable Interface Cables for Multi-Electrode Ablation Catheter and CELSIUS Catheter EUDAMED
Description: TX eco EXT Cable FDA UDI

Identifiers

Catalog Number: D135703 FDA UDI
Primary DI / UDI-DI: 10846835016796 EUDAMEDFDA UDI
Basic UDI-DI: 08468350a0003ET EUDAMED
Direct Marketing DI: 10846835016796 EUDAMED
PMA Number: P210027 FDA PMAFDA UDI
FDA Product Code: OAE FDA PMA
LPB FDA UDI
EMDN Code: Z12059080 VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Electrical-only medical device connection cable, reusable FDA UDI

Classification

Device Class: Class I EUDAMED
Class III FDA PMAFDA UDI
Market of Registration: Belgium EUDAMED
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

The QDOT MICRO System is a percutaneous cardiac ablation device designed for catheter-based cardiac electrophysiological mapping, including stimulating and recording. When used with a compatible radiofrequency generator and three-dimensional electroanatomic mapping systems, it is indicated for the treatment of Type I atrial flutter and drug-refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides real-time measurement of contact force between the catheter tip and the heart wall, as well as location information when used with the CARTO 3 Navigation System.

This system includes the QDOT MICRO Catheter, nGEN RF Generator, TX eco Cable, and TX eco EXT Cable. It is intended for use in patients aged 18 or older. The device is subject to FDA PMA and MDR authorizations.

Frequently asked questions

What is the primary use of the QDOT MICRO System?

The system is used for catheter-based cardiac electrophysiological mapping and for the treatment of specific heart rhythm disorders, including Type I atrial flutter and drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.

Does the catheter provide feedback during a procedure?

Yes, the QDOT MICRO Catheter provides real-time measurement of the contact force between the catheter tip and the heart wall, and it provides location information when used in conjunction with the CARTO 3 Navigation System.

What components are included in the QDOT MICRO System?

The system consists of the QDOT MICRO Catheter, the nGEN RF Generator, the TX eco Cable, and the TX eco EXT Cable, which work together to perform cardiac mapping and ablation.

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: BIOSENSE WEBSTER INC QDOT MICRO - accessdata.fda.gov, QDOT MICRO™ Catheter | Biosense Webster - J&J MedTech, nGEN™ Generator for Ablation Systems | PDF - Scribd, [PDF] nGEN™ Generator User Manual - MSA, [PDF] Biosense Webster

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class III	Active
FDA PMA	United States	FDA_PMA	P210027	Class III	Active

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Manufacturer

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

Sources (3)

FDA PMA P210027 23 fields · synced Sep 18, 2026
FDA UDI 9910ccd8-2814-404e-a65b-d51a801cc0f0 37 fields · synced May 30, 2026
EUDAMED 8f2d819d-fdd1-447b-bb4c-fc711e94dbb8 61 fields · synced Jul 27, 2026