SIMON NITINOL FILTER

Filter, Intravascular, Cardiovascular

NITINOL MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Nitinol Medical Technologies, Inc. with the FDA for Simon Nitinol Filter.

Pre-market Notification Details

• Device ID: K940489
• 510k Number: K940489
• Device Name: SIMON NITINOL FILTER
• Classification: Filter, Intravascular, Cardiovascular
• Applicant: NITINOL MEDICAL TECHNOLOGIES, INC. 374 CONGRESS STREET, SUITE 605 Boston, MA 02210
• Contact: Stephen J Kleshinski
• Correspondent: Stephen J Kleshinski; NITINOL MEDICAL TECHNOLOGIES, INC. 374 CONGRESS STREET, SUITE 605 Boston, MA 02210
• Product Code: DTK
• CFR Regulation Number: 870.3375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-01-25
• Decision Date: 1994-08-09