Submission Details
| 510(k) Number | K130637 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 11, 2013 |
| Decision Date | April 10, 2013 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
Apr 2013
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K130637 is an FDA 510(k) clearance for the JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 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 April 10, 2013, 30 days after receiving the submission on March 11, 2013. 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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