The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Tunneler.
| Device ID | K932273 |
| 510k Number | K932273 |
| Device Name: | CORDIS TUNNELER |
| Classification | Instrument, Shunt System Implantation |
| 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 | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-13 |
| Decision Date | 1993-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830055246 | K932273 | 000 |
| 00382830055468 | K932273 | 000 |
| 30381780034418 | K932273 | 000 |
| 30381780034395 | K932273 | 000 |