Simon Nitinol Filter/Straight Line System
FDA 510(k) K970099 · Nitinol Medical Technologies, Inc.
510(k) numberK970099
Submission
- Device name
- Simon Nitinol Filter/Straight Line System
- Applicant
- Nitinol Medical Technologies, Inc.
Boston, MA, US - Received
- January 13, 1997
- Decision date
- April 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTK – Filter, Intravascular, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3375
- Specialty
- Cardiovascular
- Implant
- Yes
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| K181202 | Sentry IVC FilterDTK · Special | Novate Medical , Ltd. | 06/06/2018SE |
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More from William Cook Europe Aps
| 510(k) | Device | Decision |
|---|---|---|
| K963016 | Simon Nitinol Filter SystemDTK · Traditional | 11/18/1996SE |
| K963014 | Simon Nitinol Filter/Straight Line SystemDTK · Traditional | 11/18/1996SE |
| K944353 | Simon Nitinol FilterDTK · Traditional | 04/28/1995SE |
| K940489 | Simon Nitinol FilterDTK · Traditional | 08/09/1994SE |
| K912144 | Simon Nitinol Filter, ModificationDTK · Traditional | 10/17/1991SE |
| K894703 | Simon Nitinol FilterDTK · Traditional | 04/20/1990SE |
Questions and answers
When was Simon Nitinol Filter/Straight Line System cleared by the FDA?
Simon Nitinol Filter/Straight Line System (K970099) received a 510(k) decision of Substantially Equivalent on April 16, 1997, 93 days after the submission was received.
What is the product code of K970099?
The FDA product code is DTK – Filter, Intravascular, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.3375.