Medical Device Manufacturer · US , Highlands Ranch , CO

Diversatek Healthcare - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2019

Recent clearances: MiVu™ Esophageal Endo Cap, Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing, Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diversatek Healthcare Gastroenterology & Urology ✕

3 devices

1-3 of 3

Cleared Apr 25, 2023

MiVu™ Esophageal Endo Cap

Gastroenterology & Urology · 106d

Cleared Nov 08, 2022

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

Gastroenterology & Urology · 60d

Cleared Oct 03, 2019

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

Gastroenterology & Urology · 241d