PASSPORT

Dilator, Catheter, Ureteral

BOSTON SCIENTIFIC CORP.

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

Pre-market Notification Details

• Device ID: K941853
• 510k Number: K941853
• Device Name: PASSPORT
• Classification: Dilator, Catheter, Ureteral
• Applicant: BOSTON SCIENTIFIC CORP. 480 PLEASANT ST. Watertown, MA 02472 -2407
• Contact: Lorraine M Hanley
• Correspondent: Lorraine M Hanley; BOSTON SCIENTIFIC CORP. 480 PLEASANT ST. Watertown, MA 02472 -2407
• Product Code: EZN
• CFR Regulation Number: 876.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-04-14
• Decision Date: 1994-09-12