Submission Details
| 510(k) Number | K071427 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 23, 2007 |
| Decision Date | August 30, 2007 |
| Days to Decision | 99 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Aug 2007
Decision
99d
Days
Class 2
Risk
About This 510(k) Submission
K071427 is an FDA 510(k) clearance for the DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS, 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 August 30, 2007, 99 days after receiving the submission on May 23, 2007. 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
Similar Devices — MCW Catheter, Peripheral, Atherectomy
All 144
K250723 · Cardio Flow Inc.,
· Apr 2025
K250385 · Spectranetics
· Mar 2025
K242757 · Bard Peripheral Vascular, Inc.
· Jan 2025
K242947 · Cardio Flow Inc.,
· Nov 2024
K241553 · Eximo Medical, Ltd.
· Jun 2024
K233483 · Cardio Flow Inc.,
· Feb 2024
More from Cardiovascular Systems, Inc.
View all
K220109
· MCW · Mar 2022
K212725
· DQY · Sep 2021
K210586
· MCW · Sep 2021
K211240
· DQY · Aug 2021
K211251
· DQY · May 2021