BIONECTOR

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

VYGON CORP.

The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Bionector.

Pre-market Notification Details

• Device ID: K941678
• 510k Number: K941678
• Device Name: BIONECTOR
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: VYGON CORP. ONE MADISON ST. East Rutherford, NJ 07073
• Contact: Roger M Severn
• Correspondent: Roger M Severn; VYGON CORP. ONE MADISON ST. East Rutherford, NJ 07073
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-04-05
• Decision Date: 1995-06-26