Submission Details
| 510(k) Number | K142429 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 29, 2014 |
| Decision Date | December 24, 2014 |
| Days to Decision | 117 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Special
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
Dec 2014
Decision
117d
Days
Class 2
Risk
About This 510(k) Submission
K142429 is an FDA 510(k) clearance for the CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on December 24, 2014, 117 days after receiving the submission on August 29, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.
Device Classification
| Product Code | HCG — Device, Neurovascular Embolization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5950 |
Manufacturer
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