The following data is part of a premarket notification filed by Nitinol Medical Technologies, Inc. with the FDA for Simon Nitinol Filter, Modification.
| Device ID | K912144 |
| 510k Number | K912144 |
| Device Name: | SIMON NITINOL FILTER, MODIFICATION |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | NITINOL MEDICAL TECHNOLOGIES, INC. 101 PARK AVE. New York, NY 10178 |
| Contact | Leonard Gordon |
| Correspondent | Leonard Gordon NITINOL MEDICAL TECHNOLOGIES, INC. 101 PARK AVE. New York, NY 10178 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-13 |
| Decision Date | 1991-10-17 |