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: K944353
• 510k Number: K944353
• Device Name: SIMON NITINOL FILTER
• Classification: Filter, Intravascular, Cardiovascular
• Applicant: NITINOL MEDICAL TECHNOLOGIES, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109
• Contact: Jonathan S Kahan
• Correspondent: Jonathan S Kahan; NITINOL MEDICAL TECHNOLOGIES, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109
• Product Code: DTK
• CFR Regulation Number: 870.3375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-30
• Decision Date: 1995-04-28