Submission Details
| 510(k) Number | K082981 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 06, 2008 |
| Decision Date | October 31, 2008 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
Oct 2008
Decision
25d
Days
Class 2
Risk
About This 510(k) Submission
K082981 is an FDA 510(k) clearance for the DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT, 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 October 31, 2008, 25 days after receiving the submission on October 6, 2008. 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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