CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC

Introducer, Catheter

CREGANNA MEDICAL DEVICES

The following data is part of a premarket notification filed by Creganna Medical Devices with the FDA for Creganna-tactx Steerable Sheath Set Symmetric.

Pre-market Notification Details

• Device ID: K131079
• 510k Number: K131079
• Device Name: CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
• Classification: Introducer, Catheter
• Applicant: CREGANNA MEDICAL DEVICES 386 WEST MAIN STREET SUITE 7 Northborough, MA 01532
• Contact: Christine Nichols
• Correspondent: Christine Nichols; CREGANNA MEDICAL DEVICES 386 WEST MAIN STREET SUITE 7 Northborough, MA 01532
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-04-17
• Decision Date: 2013-08-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391526210086	K131079	000
05391526210079	K131079	000
05391526210062	K131079	000
05391526210055	K131079	000
05391526210048	K131079	000
05391526210031	K131079	000