The following data is part of a premarket notification filed by Nitinol Medical Technologies, Inc. with the FDA for Simon Nitinol Filter System.
| Device ID | K963016 |
| 510k Number | K963016 |
| Device Name: | SIMON NITINOL FILTER SYSTEM |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | NITINOL MEDICAL TECHNOLOGIES, INC. 263 SUMMER ST., 7TH FLOOR Boston, MA 02210 -1503 |
| Contact | Sherrie Coval-goldsmith |
| Correspondent | Sherrie Coval-goldsmith NITINOL MEDICAL TECHNOLOGIES, INC. 263 SUMMER ST., 7TH FLOOR Boston, MA 02210 -1503 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-02 |
| Decision Date | 1996-11-18 |
| Summary: | summary |