Guardia™ Access Nano And Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter

Catheter, Assisted Reproduction

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Guardia™ Access Nano And Soft-trans Embryo Transfer Catheter Sets, Soft-trans Embryo Transfer Catheter, Soft-trans Guide Catheter.

Pre-market Notification Details

• Device ID: K172051
• 510k Number: K172051
• Device Name: Guardia™ Access Nano And Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
• Classification: Catheter, Assisted Reproduction
• Applicant: Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
• Contact: Naomi Funkhouser
• Correspondent: Naomi Funkhouser; Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
• Product Code: MQF
• CFR Regulation Number: 884.6110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-06
• Decision Date: 2018-01-10
• Summary: summary