Cleared Traditional

Tigertriever and Tigertriever 17 Revascularization Devce

K203592 · Rapid Medical , Ltd. · Neurology

Mar 2021

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K203592 is an FDA 510(k) clearance for the Tigertriever and Tigertriever 17 Revascularization Devce, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Rapid Medical , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on March 23, 2021, 105 days after receiving the submission on December 8, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K203592 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2020
Decision Date	March 23, 2021
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.