FDA.reportPublic FDA data

510(k) K190813

Device
CrossBay Cervical Dilator Catheter System
Applicant
CrossBay Medical
510(k) number
K190813
Product code
PON  
Decision
Substantially Equivalent (SESE)
Decision date
2019-08-23
Date received
2019-03-29
Regulation
884.4260
Classification name
Catheter, Balloon, Dilation Of Cervical Canal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Piush Vidyarthi
Address
13240 Evening Creek Dr., Suite 304 San Diego CA US 92128 92128

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PON  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC2021-10-15
K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC2020-11-06
K160664Aqueduct 100 Cervical DilatorGtimd, LLC2016-08-01

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases