The following data is part of a premarket notification filed by Cardiovascular Systems, Inc. with the FDA for Diamondback 360 Peripheral Orbital Atherectomy System.
Device ID | K133999 |
510k Number | K133999 |
Device Name: | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
Classification | Catheter, Peripheral, Atherectomy |
Applicant | CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DRIVE Saint Paul, MN 55112 |
Contact | Blair Buth |
Correspondent | Blair Buth CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DRIVE Saint Paul, MN 55112 |
Product Code | MCW |
CFR Regulation Number | 870.4875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-27 |
Decision Date | 2014-02-28 |
Summary: | summary |