510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222187Substantially Equivalent

Multistage Balloon Dilatation Catheter

Dongguan TT Medical, Inc., Dongguan, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222187 is the FDA 510(k) clearance record for Multistage Balloon Dilatation Catheter, a class II device, cleared for Dongguan TT Medical, Inc. on under FDA product code KTI (Bronchoscope Accessory). FDA's definition for product code KTI reads: "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...". FDA records list 6 510(k) clearances for Dongguan TT Medical, Inc., from to . As of , FDA records show no recalls naming K222187.

Clearance record

Decision date
Received
(222 days to decision)
Product code
KTI Bronchoscope Accessory
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Dongguan TT Medical, Inc. Bld#1, 1 Taoyuan Rd., Songshan Lake, Dongguan, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KTI

Trailing 12 months
4 clearances under product code KTI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KTI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260