Cleared Traditional

Elation Pulmonary Balloon Dilation Catheter

K213434 · Merit Medical Systems, Inc. · Ear, Nose, Throat

Mar 2022

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K213434 is an FDA 510(k) clearance for the Elation Pulmonary Balloon Dilation Catheter, a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 8, 2022, 137 days after receiving the submission on October 22, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K213434 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 22, 2021
Decision Date	March 08, 2022
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	KTI — Bronchoscope Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).