Cleared Traditional

Tigertriever 13 Revascularization Device

K220808 · Rapid Medical , Ltd. · Neurology

Jul 2022

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K220808 is an FDA 510(k) clearance for the Tigertriever 13 Revascularization Device, 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 July 25, 2022, 129 days after receiving the submission on March 18, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K220808 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2022
Decision Date	July 25, 2022
Days to Decision	129 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.