K884554 is an FDA 510(k) clearance for the PERITONEAL CATHETER STABILIZATION DEVICE 5C4381. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on January 31, 1989, 92 days after receiving the submission on October 31, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K884554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1988 |
| Decision Date | January 31, 1989 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKX — System, Peritoneal, Automatic Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |