The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit With Tuohy-borst Adapter,codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit.
| Device ID | K153347 |
| 510k Number | K153347 |
| Device Name: | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit With Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Megan Herman |
| Correspondent | Megan Herman CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-20 |
| Decision Date | 2016-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780514534 | K153347 | 000 |
| 10886704080442 | K153347 | 000 |
| 10886704080459 | K153347 | 000 |
| 10886704080466 | K153347 | 000 |
| 10886704080473 | K153347 | 000 |
| 10381780514510 | K153347 | 000 |
| 10381780514558 | K153347 | 000 |
| 10381780514473 | K153347 | 000 |
| 10381780514497 | K153347 | 000 |
| 10886704080435 | K153347 | 000 |