VersaCross Transseptal Sheath

Introducer, Catheter

Baylis Medical Company Inc.

The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Versacross Transseptal Sheath.

Pre-market Notification Details

• Device ID: K183655
• 510k Number: K183655
• Device Name: VersaCross Transseptal Sheath
• Classification: Introducer, Catheter
• Applicant: Baylis Medical Company Inc. 2645 Matheson Blvd. East Mississauga, CA L4w 4j1
• Contact: Meghal Khakhar
• Correspondent: Meghal Khakhar; Baylis Medical Company Inc. 2645 Matheson Blvd. East Mississauga, CA L4w 4j1
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-27
• Decision Date: 2019-05-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00685447005285	K183655	000
00685447005452	K183655	000
00685447005469	K183655	000
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