Who else makes this device?

Name: EasyConnect MAP Cable
Brand: EasyConnect MAP Cable

Cardiovascular › DiagnosticCatheter, Electrode Recording, Or Probe, Electrode Recording

EasyConnect MAP Cable

EasyConnect MAP connection cables realize a safe, quick and interference-free connection of your MedFact MAP-Catheter (MagnoMap MAP and EasyMap MAP) to your EP-System. These cables are not…

Registry build 21.09.26

EasyConnect MAP connection cables realize a safe, quick and interference-free connection of your MedFact MAP-Catheter (MagnoMap MAP and EasyMap MAP) to your EP-System. These cables are not included in the delivery of the catheter and must be ordered separately. On the catheter side the cable has a quadropolare REDEL connector; on the EP-System side four 2mm shrouded pin connectors. For EP-Systems that are not yet equipped for shrouded pins acceptance 2mm pin connectors EasyConnect Pin or screw-in connectors EasyConnect Screw are available.

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (2), Tianjin (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DRF
Manufacturer	City	Province	Registered as	Device types
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Palconn Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	2
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Tianjin Ethylene Oxide Sterilization Technology Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	4
Shanghai Microport EP Medtech Co., Ltd.	Shanghai	Shanghai	Manufacturer	3

Record

Regulatory record for EasyConnect MAP Cable
Listed by	MedFact Engineering GmbH, Germany
FDA product code	DRF
Device type	Catheter, Electrode Recording, Or Probe, Electrode Recording
Device class	Class 2
Regulation	21 CFR 870.1220
Establishment	Contract manufacturer, Complaint-file establishment, Manufacturer
510(k)	K151139
Record published	2026-01-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for EasyConnect MAP Cable
Catalogue number	Size	Status
MF0001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Map-iT	Access Point Medical, LLC	420
Woven	Boston Scientific Corporation	126
Inquiry™	Irvine Biomedical. Inc.	122
Webster	Biosense Webster, Inc.	121
Viking™	Boston Scientific Corporation	81
EasyFinder Fixed Curve Diagnostic Catheter	Shanghai Microport EP Medtech Co., Ltd.	56
Supreme™	St. Jude Medical Cardiovascular Division	55
Celsius	Biosense Webster, Inc.	47
Response™	St. Jude Medical Cardiovascular Division	46
Torqr™	Medtronic, Inc.	32
Catheter, Electrode Recording, Or Probe, Electrode Recording	Medtronic, Inc.	27
Lasso NAV	Biosense Webster, Inc.	22

Showing 12 of 112. All products under Catheter, Electrode Recording, Or Probe, Electrode Recording

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K151139	2016-10-18

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P950005	2001-10-05	CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER	Biosense Webster, Inc.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.