Submission Details
| 510(k) Number | K122916 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 21, 2012 |
| Decision Date | October 19, 2012 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
Oct 2012
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K122916 is an FDA 510(k) clearance for the JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Medrad, Inc. (Kirkland, US). The FDA issued a Cleared decision on October 19, 2012, 28 days after receiving the submission on September 21, 2012. 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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