Interface Cable for Multi-Electrode Ablation Catheters nMARQ
FDA PMAFDA UDIEUDAMEDClass III (US FDA PMA)
Identity
- Trade Name
- INTERFACE CABLE EUDAMEDBIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS FDA PMACARTO 3 FDA UDIN/A FDA UDI
- Generic Name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter FDA PMAElectrical-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
- Model / Reference
- D128622 EUDAMEDFDA UDID128709 EUDAMEDFDA UDISMARTABLATE 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 EUDAMEDSW1170005 EUDAMEDD133703 EUDAMEDSW1170016 EUDAMEDC6MR10EPTRS FDA UDIC10MR10MSTKS FDA UDI
Identifiers
- Catalog Number
- D128622 FDA UDIC6MR10EPTRS FDA UDID128709 FDA UDIC10MR10MSTKS FDA UDI
- Primary DI / UDI-DI
- 10846835008883 EUDAMEDFDA UDI10846835003666 EUDAMEDFDA UDI10846835008913 EUDAMEDFDA UDI10846835000184 EUDAMEDFDA UDI10846835021493 EUDAMED
- Basic UDI-DI
- 08468350a0003ET EUDAMED
- Direct Marketing DI
- 10846835003666 EUDAMED10846835021493 EUDAMED10846835008883 EUDAMED10846835008913 EUDAMED10846835000184 EUDAMED
- 510(k) Number
- K090017 FDA UDI
- FDA Product Code
- OAD FDA PMAFDA UDIDQK 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 EUDAMEDClass III FDA PMAFDA UDIClass II FDA UDI
- Regulation Number
- 870.1425 FDA 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Interface Cable for Multi-Electrode Ablation Catheters is an accessory component designed to support cardiac electrophysiological mapping and ablation procedures. It facilitates the connection between specialized diagnostic and ablation catheters and the necessary clinical equipment required for stimulating and recording cardiac activity.
This device is intended for use in conjunction with Biosense Webster Navistar and Celsius Thermocool deflectable tip catheters. These systems are utilized in clinical settings for catheter-based cardiac mapping and the treatment of type I atrial flutter in patients aged 18 or older. The cable is part of a system that may include the Stockert 70 generator and the Carto EP/XP navigation system for location information.
Frequently asked questions
What is the primary function of this interface cable?
The interface cable serves as a connection accessory for multi-electrode ablation catheters, enabling the transmission of signals required for cardiac electrophysiological mapping, stimulating, and recording.
Which catheters are compatible with this interface cable?
This cable is designed for use with Biosense Webster Navistar and Celsius Thermocool deflectable tip diagnostic and ablation catheters, including various models such as the NS75T and D7IT series.
Is this device used for treating specific heart conditions?
Yes, when used with the compatible Navistar or Celsius Thermocool catheters and the Stockert 70 generator, the system is indicated for the treatment of type I atrial flutter in patients 18 years of age or older.
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: Premarket Approval (PMA) - FDA, Multi-electrode balloon catheter with circumferential and point ..., PVAC®vs. nMARQ™for atrial fibrillation ablation - ResearchGate, Biosense Webster Каталог 2015 PDF - Scribd, Invasive strategies for rhythm control of atrial fibrillation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | European Union | MDR | — | Class III | Pending data |
| FDA PMA | United States | FDA_PMA | P030031 | Class III | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (10)
- FDA PMA P030031 24 fields · synced Sep 18, 2026
- FDA UDI 906600d3-1382-4fdc-9f7e-583d4d079d2a 36 fields · synced May 29, 2026
- FDA UDI 9dcb0fe7-ce00-4b9c-8ef2-a00a0ff3f692 36 fields · synced May 30, 2026
- FDA UDI 45da2367-4c5f-4dbe-8d9a-fb11ee242cf2 36 fields · synced May 30, 2026
- FDA UDI dc9ec1d5-90d4-4c98-9968-f7e112741e17 36 fields · synced May 30, 2026
- EUDAMED 618d606b-4173-482b-92f1-c2a4f1e6e1aa 61 fields · synced Jul 11, 2026
- EUDAMED 468c10e2-f6e8-4b29-be9d-9d9ede159f15 61 fields · synced Jul 11, 2026
- EUDAMED 6e3b1d09-8824-47f8-9218-1e5df0f4d7e2 61 fields · synced Jul 18, 2026
- EUDAMED fbe19c1e-d0c3-41f2-9eb3-9291d0961ea4 61 fields · synced Jul 22, 2026
- EUDAMED 21baef24-fc1e-403c-abfe-1c1269d32a3d 61 fields · synced Jul 23, 2026