Submission Details
| 510(k) Number | K140673 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 18, 2014 |
| Decision Date | April 16, 2014 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
INSERTION TOOL
Apr 2014
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K140673 is an FDA 510(k) clearance for the INSERTION TOOL, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on April 16, 2014, 29 days after receiving the submission on March 18, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
Device Classification
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1330 |
Manufacturer
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