510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dongguan TT Medical, Inc.

Dongguan Guangdong, CN

DONGGUAN TT MEDICAL, INC. appears in FDA device records in Dongguan Guangdong, CN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Dongguan TT Medical, Inc. between 2023 and 2026. The busiest year on record is 2023, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Dongguan TT Medical, Inc., by decision year
YearClearances
20234
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260437Valvuloplasty Balloon Catheter (ValvuloPro)OZTSubstantially Equivalent
K240967ValvuloPro Valvuloplasty Balloon CatheterOZTSubstantially Equivalent
K231814ValvuloPro Valvuloplasty Balloon CatheterOZTSubstantially Equivalent
K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)LOXSubstantially Equivalent
K222663MultiStage Balloon Dilatation CatheterFGESubstantially Equivalent
K222187Multistage Balloon Dilatation CatheterKTISubstantially Equivalent

Registered establishments

FDA registered establishments for Dongguan TT Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30131523013013152301DONGGUAN TT MEDICAL, INC.Bld# 1, 1 Taoyuan Road,, Dongguan Guangdong 523808 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain