D*Clot® HD Rotational Thrombectomy System

Basic Information

• Brand Name: D*Clot® HD Rotational Thrombectomy System
• Primary DI: 15711055004333
• Version / Model: D*Clot® HD 6Fx65CM
• Catalog Number: T10106065
• Company Name: Mermaid Medical A/S
• Labeler DUNS: 308951313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-16
• Public Version: 1
• Public Version Date: 2020-03-24
• Public Version Status: New
• Public Device Record Key: 9ffa0a90-2617-4313-9674-8f55345172a1

Device Description

The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts

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: Yes
• 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: 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
DXE	Catheter, Embolectomy	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58172	Thrombectomy rotational catheter	A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may 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	15711055004333	GS1
Package	05711055004336	GS1	Shelfbox	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021641	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6F	French
Catheter Length	65	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius