The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Intracranial Pressure Monitoring Cup Catheters.
| Device ID | K854657 |
| 510k Number | K854657 |
| Device Name: | INTRACRANIAL PRESSURE MONITORING CUP CATHETERS |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Contact | David Kornhauser |
| Correspondent | David Kornhauser CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-20 |
| Decision Date | 1985-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2729101261 | K854657 | 000 |
| M2729101251 | K854657 | 000 |