The following data is part of a premarket notification filed by Nitinol Medical Technologies, Inc. with the FDA for Simon Nitinol Filter.
Device ID | K894703 |
510k Number | K894703 |
Device Name: | SIMON NITINOL FILTER |
Classification | Filter, Intravascular, Cardiovascular |
Applicant | NITINOL MEDICAL TECHNOLOGIES, INC. 7779 WILLOW GLEN RD. Los Angles, CA 90046 -1610 |
Contact | Jack Reinstein |
Correspondent | Jack Reinstein NITINOL MEDICAL TECHNOLOGIES, INC. 7779 WILLOW GLEN RD. Los Angles, CA 90046 -1610 |
Product Code | DTK |
CFR Regulation Number | 870.3375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-24 |
Decision Date | 1990-04-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SIMON NITINOL FILTER 73747821 1556677 Live/Registered |
NITINOL MEDICAL TECHNOLOGIES, INC. 1988-08-23 |