The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Micrusframe 10 Stretch Resistant Microcoil Delivery System, Micrusframe 18 Stretch Resistant Microcoil Delivery System, Deltafill 18 Stretch Resistant Microcoil Delivery System, Deltaxsft 10 Stretch Resistant Microcoil Delivery System, Galaxy G3 Fill.
| Device ID | K171747 |
| 510k Number | K171747 |
| Device Name: | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL |
| Classification | Device, Neurovascular Embolization |
| Applicant | Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Contact | Vivian Perez |
| Correspondent | Yolanda Bolanos Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-13 |
| Decision Date | 2017-07-14 |
| Summary: | summary |