IBAG

Collector, Urine, (and Accessories) For Indwelling Catheter

FUTURE PATH MEDICAL, LLC

The following data is part of a premarket notification filed by Future Path Medical, Llc with the FDA for Ibag.

Pre-market Notification Details

• Device ID: K110518
• 510k Number: K110518
• Device Name: IBAG
• Classification: Collector, Urine, (and Accessories) For Indwelling Catheter
• Applicant: FUTURE PATH MEDICAL, LLC 8870 RAVELLO CT Naples, FL 34114
• Contact: Daniel Kamm
• Correspondent: Daniel Kamm; FUTURE PATH MEDICAL, LLC 8870 RAVELLO CT Naples, FL 34114
• Product Code: KNX
• CFR Regulation Number: 876.5250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-02-23
• Decision Date: 2011-06-24
• Summary: summary