Submission Details
| 510(k) Number | K111388 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 17, 2011 |
| Decision Date | July 26, 2011 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
Jul 2011
Decision
70d
Days
Class 2
Risk
About This 510(k) Submission
K111388 is an FDA 510(k) clearance for the DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Cardiovascular Systems, Inc. (Saint Paul, US). The FDA issued a Cleared decision on July 26, 2011, 70 days after receiving the submission on May 17, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.
Device Classification
| Product Code | MCW — Catheter, Peripheral, Atherectomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4875 |
Manufacturer
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