FDA.reportPublic FDA data

510(k) K222187

Device
Multistage Balloon Dilatation Catheter
Applicant
Dongguan TT Medical, Inc.
510(k) number
K222187
Product code
KTI
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-01
Date received
2022-07-22
Regulation
874.4680
Classification name
Bronchoscope Accessory
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yuying Bi
Address
Bld#1, 1 Taoyuan Rd., Songshan Lake Dongguan CN 523808 523808

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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