The following data is part of a premarket notification filed by Nitinol Medical Technologies, Inc. with the FDA for Simon Nitinol Filter/straight Line System.
| Device ID | K970099 |
| 510k Number | K970099 |
| Device Name: | SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | NITINOL MEDICAL TECHNOLOGIES, INC. 27 WORMWOOD ST. Boston, MA 02210 |
| Contact | Sherrie Coval-goldsmith |
| Correspondent | Sherrie Coval-goldsmith NITINOL MEDICAL TECHNOLOGIES, INC. 27 WORMWOOD ST. Boston, MA 02210 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-13 |
| Decision Date | 1997-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741109218 | K970099 | 000 |
| 00801741109195 | K970099 | 000 |
| 00801741109188 | K970099 | 000 |
| 00801741040924 | K970099 | 000 |
| 00801741040917 | K970099 | 000 |
| 00801741040900 | K970099 | 000 |