Multistage Balloon Dilatation Catheter— 510(k) K222187

Substantially Equivalent

Dongguan TT Medical, Inc.

FDA 510(k) clearance K222187 for Multistage Balloon Dilatation Catheter, Substantially Equivalent on 2023-03-01. Applicant: Dongguan TT Medical, Inc..

Clearance details

Applicant: Dongguan TT Medical, Inc.
Product code: Code KTI
Advisory panel: Ear, Nose, Throat
Date received: 2022-07-22
Decision date: 2023-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.