NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000

• K Number: K090932
• Device Name: NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000
• Manufacturer: NEXGEN MEDICAL SYSTEMS, INC.
• Date Cleared: 2009-09-24 ( 175 days)
• Product Code: QEW , DXE
• Regulation Number: 870.5150
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The NexGen Peripheral Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arterial blood vessels and peripheral bypass grafts and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text primarily consists of an FDA 510(k) clearance letter for the NexGen Peripheral Mechanical Retrieval Device. It discusses the device's regulatory classification, product codes, and general compliance requirements.

However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about clinical performance, test sets, expert involvement, or training data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from the provided text.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).