AcQCross Qx Integrated Transseptal Dilator/Needle

Basic Information

• Brand Name: AcQCross Qx Integrated Transseptal Dilator/Needle
• Primary DI: 00850027837598
• Version / Model: 900308
• Company Name: ACUTUS MEDICAL, INC.
• Labeler DUNS: 844418199
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-21
• Public Version: 2
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 575134fb-670b-4941-8a0c-2fe75fe601a6

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DYB	Introducer, Catheter	Cardiovascular	870.1340	2
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	870.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65073	Cardiac transseptal access electrosurgical dilator/needle	A luminal, one-piece, electrosurgical device designed to be used with a transseptal vascular guide-catheter (not included) to penetrate the interatrial septum for left-heart access during a transseptal catheterization procedure. It is typically a long, thin tube that is curved and round-nosed at the distal end for positioning against the atrial septum, and incorporates an extendable, sharp needle in its lumen able to apply radio-frequency (RF) alternating current in a monopolar configuration. It may have radiopaque markers for positioning and enable acquisition of an intracardiac electrocardiogram (ECG); a guidewire and connection cables may also be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850027837598	GS1