Submission Details
| 510(k) Number | K142259 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 14, 2014 |
| Decision Date | September 10, 2014 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Direxion Torqueable Microcatheter
Sep 2014
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K142259 is an FDA 510(k) clearance for the Direxion Torqueable Microcatheter, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on September 10, 2014, 27 days after receiving the submission on August 14, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.
Device Classification
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1210 |
Manufacturer
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