The following data is part of a premarket notification filed by Codman & Shurtleff, Inc with the FDA for Cerelink Icp Sensor Basic Kit, Cerelink Icp Sensor Metal Skull Bolt Kit, Cerelink Icp Sensor Plastic Skull Bolt Kit, Cerelink Icp Sensor Ventricular Catheter Kit.
| Device ID | K173192 |
| 510k Number | K173192 |
| Device Name: | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Codman & Shurtleff, Inc 325 Paramount Drive Raynham, MA 02767 |
| Contact | Megan Palumbo |
| Correspondent | Megan Palumbo Codman & Shurtleff, Inc 325 Paramount Drive Raynham, MA 02767 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2017-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780520696 | K173192 | 000 |
| 10381780520689 | K173192 | 000 |
| 10381780520672 | K173192 | 000 |
| 10381780520702 | K173192 | 000 |
| 10886704075462 | K173192 | 000 |
| 10886704075455 | K173192 | 000 |
| 10886704075448 | K173192 | 000 |
| 10886704075431 | K173192 | 000 |