AcQRate Dx Fixed Curve Catheter

Basic Information

• Brand Name: AcQRate Dx Fixed Curve Catheter
• Primary DI: 04260090928868
• Version / Model: 4J 6F 5 mm Soft Tip
• Catalog Number: 460645
• Company Name: VascoMed GmbH
• Labeler DUNS: 322983446
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-22
• Public Version: 1
• Public Version Date: 2021-11-01
• Public Version Status: New
• Public Device Record Key: a34e848a-2366-4f56-9d87-f2dede613266

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING	Cardiovascular	870.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46355	Cardiac mapping catheter, percutaneous, single-use	A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260090928868	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201445	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Length: 110 cm
Device Size Text, specify			Diameter: 6 French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight.