XCATH

Introducer, Catheter

ALSEAL

The following data is part of a premarket notification filed by Alseal with the FDA for Xcath.

Pre-market Notification Details

• Device ID: K133296
• 510k Number: K133296
• Device Name: XCATH
• Classification: Introducer, Catheter
• Applicant: ALSEAL 1468 Harwell Avenue Crofton, MD 21114
• Contact: Yolanda Smith
• Correspondent: Yolanda Smith; ALSEAL 1468 Harwell Avenue Crofton, MD 21114
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-25
• Decision Date: 2014-02-14
• Summary: summary