The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Horizontal-verical Valve System.
| Device ID | K944595 |
| 510k Number | K944595 |
| Device Name: | CORDIS HORIZONTAL-VERICAL VALVE SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Marvin L Sussman |
| Correspondent | Marvin L Sussman CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1995-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830056250 | K944595 | 000 |
| 10381780034247 | K944595 | 000 |