Cleared Traditional

Multistage Balloon Dilatation Catheter

K222187 · Dongguan TT Medical, Inc. · Ear, Nose, Throat

Mar 2023

Decision

222d

Days

Class 2

Risk

About This 510(k) Submission

K222187 is an FDA 510(k) clearance for the Multistage Balloon Dilatation Catheter, a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Dongguan TT Medical, Inc. (Dongguan, CN). The FDA issued a Cleared decision on March 1, 2023, 222 days after receiving the submission on July 22, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K222187 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2022
Decision Date	March 01, 2023
Days to Decision	222 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).