The following data is part of a premarket notification filed by Codman & Shurtleff, Inc with the FDA for Galaxy G3 Mini Microcoil Delivery System.
| Device ID | K171862 |
| 510k Number | K171862 |
| Device Name: | GALAXY G3 Mini Microcoil Delivery System |
| Classification | Device, Neurovascular Embolization |
| Applicant | Codman & Shurtleff, Inc 325 Paramount Drive Raynham, MA 02767 |
| Contact | Yoon Hee Beatty |
| Correspondent | Yoon Hee Beatty Codman & Shurtleff, Inc 325 Paramount Drive 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 | 2017-06-22 |
| Decision Date | 2017-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704080343 | K171862 | 000 |
| 10886704080138 | K171862 | 000 |
| 10886704080145 | K171862 | 000 |
| 10886704080152 | K171862 | 000 |
| 10886704080206 | K171862 | 000 |
| 10886704080213 | K171862 | 000 |
| 10886704080220 | K171862 | 000 |
| 10886704080237 | K171862 | 000 |
| 10886704080244 | K171862 | 000 |
| 10886704080251 | K171862 | 000 |
| 10886704080268 | K171862 | 000 |
| 10886704080275 | K171862 | 000 |
| 10886704080282 | K171862 | 000 |
| 10886704080299 | K171862 | 000 |
| 10886704080305 | K171862 | 000 |
| 10886704080312 | K171862 | 000 |
| 10886704080329 | K171862 | 000 |
| 10886704080336 | K171862 | 000 |
| 10886704080121 | K171862 | 000 |