The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Peritoneal Introducer & Sheath.
| Device ID | K771529 |
| 510k Number | K771529 |
| Device Name: | PERITONEAL INTRODUCER & SHEATH |
| Classification | Instrument, Shunt System Implantation |
| Applicant | CORDIS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-08 |
| Decision Date | 1977-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830055420 | K771529 | 000 |
| 00382830057431 | K771529 | 000 |
| 00382830057509 | K771529 | 000 |
| 00382830057363 | K771529 | 000 |
| 00382830057370 | K771529 | 000 |
| 30381780034425 | K771529 | 000 |
| 30381780033206 | K771529 | 000 |
| 30381780033176 | K771529 | 000 |