The following data is part of a premarket notification filed by Codman And Shurtleff, Inc. with the FDA for Deltamaxx 18 Microcoil System.
| Device ID | K120274 |
| 510k Number | K120274 |
| Device Name: | DELTAMAXX 18 MICROCOIL SYSTEM |
| Classification | Device, Neurovascular Embolization |
| Applicant | CODMAN AND SHURTLEFF, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Kim Fonda |
| Correspondent | Kim Fonda CODMAN AND SHURTLEFF, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-30 |
| Decision Date | 2012-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10878528008757 | K120274 | 000 |
| 10878528008559 | K120274 | 000 |
| 10878528008566 | K120274 | 000 |
| 10878528008573 | K120274 | 000 |
| 10878528008580 | K120274 | 000 |
| 10878528008597 | K120274 | 000 |
| 10878528008603 | K120274 | 000 |
| 10878528008610 | K120274 | 000 |
| 10878528008634 | K120274 | 000 |
| 10878528008658 | K120274 | 000 |
| 10878528008672 | K120274 | 000 |
| 10878528008696 | K120274 | 000 |
| 10878528008719 | K120274 | 000 |
| 10878528008733 | K120274 | 000 |
| 10878528008542 | K120274 | 000 |