# K970099: Simon Nitinol Filter/Straight Line System

- Pathway: 510(k) (Traditional)
- Applicant: Nitinol Medical Technologies, Inc.
- Decided: Apr 16, 1997 after 93 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: 2 generations back to K894703 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963014: Simon Nitinol Filter/Straight Line System, Nitinol Medical Technologies, Inc. (1996) Summary page 2.
- K963016: Simon Nitinol Filter System, Nitinol Medical Technologies, Inc. (1996) Summary page 2.

## Indications for use
The intended use of both Systems is to prevent embolisms from migrating to the pulmonary arteries.

Source page: https://510kreport.com/device/K970099
Methodology: https://510kreport.com/methodology