Submission Details
| 510(k) Number | K133208 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 2013 |
| Decision Date | November 14, 2013 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Nov 2013
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K133208 is an FDA 510(k) clearance for the INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on November 14, 2013, 27 days after receiving the submission on October 18, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.
Device Classification
| Product Code | KRD — Device, Vascular, For Promoting Embolization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3300 |
Manufacturer
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