The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Csf Reservoir.
| Device ID | K950315 |
| 510k Number | K950315 |
| Device Name: | CORDIS CSF RESERVOIR |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intraventricular |
| Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Contact | Marvin L Sussman |
| Correspondent | Marvin L Sussman CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Product Code | LKG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-26 |
| Decision Date | 1995-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830056212 | K950315 | 000 |
| 00382830055826 | K950315 | 000 |
| 00382830055772 | K950315 | 000 |
| 10381780034612 | K950315 | 000 |
| 10381780034605 | K950315 | 000 |
| 10381780034599 | K950315 | 000 |
| 10381780034582 | K950315 | 000 |