Submission Details
| 510(k) Number | K150319 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 09, 2015 |
| Decision Date | June 12, 2015 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
Jun 2015
Decision
123d
Days
Class 2
Risk
About This 510(k) Submission
K150319 is an FDA 510(k) clearance for the MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS, 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 June 12, 2015, 123 days after receiving the submission on February 9, 2015. 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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