The following data is part of a premarket notification filed by Lumend, Inc. with the FDA for Lumend Frontrunner Cto Coronary Catheter.
Device ID | K013284 |
510k Number | K013284 |
Device Name: | LUMEND FRONTRUNNER CTO CORONARY CATHETER |
Classification | Catheter, Percutaneous |
Applicant | LUMEND, INC. 400 CHESAPEAKE DR. Redwood City, CA 94063 |
Contact | Michael A Daniel |
Correspondent | Michael A Daniel LUMEND, INC. 400 CHESAPEAKE DR. Redwood City, CA 94063 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-02 |
Decision Date | 2002-02-11 |
Summary: | summary |