The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Standard/pediatric Cordis Hydrocephalus Valves.
| Device ID | K861377 |
| 510k Number | K861377 |
| Device Name: | STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES |
| Classification | Shunt, Central Nervous System And Components |
| 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 | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-14 |
| Decision Date | 1986-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830056236 | K861377 | 000 |
| 10381780034308 | K861377 | 000 |
| 10381780034292 | K861377 | 000 |
| 10381780035657 | K861377 | 000 |
| 10381780033387 | K861377 | 000 |
| 10381780035640 | K861377 | 000 |
| 10381780035633 | K861377 | 000 |
| 10381780034230 | K861377 | 000 |
| 10381780034223 | K861377 | 000 |
| M2729MD21021 | K861377 | 000 |
| M2729MD21011 | K861377 | 000 |
| 10381780035817 | K861377 | 000 |
| 10381780035824 | K861377 | 000 |
| 10381780035831 | K861377 | 000 |
| 00382830056052 | K861377 | 000 |
| 00382830056014 | K861377 | 000 |
| 00382830055765 | K861377 | 000 |
| 00382830055734 | K861377 | 000 |
| 00382830055611 | K861377 | 000 |
| 00382830055512 | K861377 | 000 |
| 00382830055499 | K861377 | 000 |
| 00382830055338 | K861377 | 000 |
| 00382830055321 | K861377 | 000 |
| M2729MZ110N1 | K861377 | 000 |
| M2729MD10221 | K861377 | 000 |