ULTRAFLEX

Prosthesis, Esophageal

BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Ultraflex.

Pre-market Notification Details

• Device ID: K955347
• 510k Number: K955347
• Device Name: ULTRAFLEX
• Classification: Prosthesis, Esophageal
• Applicant: BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537
• Contact: Daniel J Dillon
• Correspondent: Daniel J Dillon; BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537
• Product Code: ESW
• CFR Regulation Number: 878.3610 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-11-21
• Decision Date: 1996-02-16