EsoFLIP® ES-310 Balloon Catheter

Esophageal Dilator With Balloon And Electrode Sensors

Crospon Ltd.

The following data is part of a premarket notification filed by Crospon Ltd. with the FDA for Esoflip® Es-310 Balloon Catheter.

Pre-market Notification Details

• Device ID: K172128
• 510k Number: K172128
• Device Name: EsoFLIP® ES-310 Balloon Catheter
• Classification: Esophageal Dilator With Balloon And Electrode Sensors
• Applicant: Crospon Ltd. Galway Business Park Dangan Galway, IE
• Contact: John O’dea
• Correspondent: Paul Dryden; Crospon Ltd., C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704
• Product Code: PIE
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-14
• Decision Date: 2017-11-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884521809434	K172128	000