The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/xsft Stretch Resistant Microcoil Delivery Systems.
| Device ID | K150319 |
| 510k Number | K150319 |
| Device Name: | MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS |
| Classification | Device, Neurovascular Embolization |
| Applicant | CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Hannah Foley |
| Correspondent | Hannah Foley CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-06-12 |
| Summary: | summary |