The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Hydrocephalus Valves, Catheters & Accessories (bundled).
| Device ID | K172022 |
| 510k Number | K172022 |
| Device Name: | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Contact | Christopher Garete |
| Correspondent | Christopher Garete Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2017-10-03 |
| Summary: | summary |