The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Easy Rider Micro Catheter.
Device ID | K974473 |
510k Number | K974473 |
Device Name: | EASY RIDER MICRO CATHETER |
Classification | Catheter, Continuous Flush |
Applicant | MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
Contact | Tom Daughters |
Correspondent | Tom Daughters MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-26 |
Decision Date | 1998-06-17 |
Summary: | summary |