Cleared Traditional

Cardiovascular Angiography System

K220311 · Allengers Medical Systems Limited · Radiology

May 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K220311 is an FDA 510(k) clearance for the Cardiovascular Angiography System, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Allengers Medical Systems Limited (Derabassi, Distt. Mohali, IN). The FDA issued a Cleared decision on May 3, 2022, 90 days after receiving the submission on February 2, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K220311 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2022
Decision Date	May 03, 2022
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy