# K963014: Simon Nitinol Filter/Straight Line System

- Pathway: 510(k) (Traditional)
- Applicant: Nitinol Medical Technologies, Inc.
- Decided: Nov 18, 1996 after 108 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894703 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944353: Simon Nitinol Filter, Nitinol Medical Technologies, Inc. (1995) Summary page 2.
- K940489: Simon Nitinol Filter, Nitinol Medical Technologies, Inc. (1994) Summary page 2.
- K912144: Simon Nitinol Filter, Modification, Nitinol Medical Technologies, Inc. (1991) Summary page 2.
- K894703: Simon Nitinol Filter, Nitinol Medical Technologies, Inc. (1990) Summary page 2.

## Most influential descendants
- K970099: Simon Nitinol Filter/Straight Line System (1997), 0 descendants of its own

## Indications for use
The intended use of Nitinol Medical Technologies, Inc.’s (“NMT”) Simon Nitinol Filter/Straight Line™ System (“SNF/SL System”) is to prevent pulmonary embolisms from migrating to the pulmonary arteries.

Source page: https://510kreport.com/device/K963014
Methodology: https://510kreport.com/methodology