K871050 is an FDA 510(k) clearance for the CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.. This device is classified as a Set, Administration, For Peritoneal Dialysis, Disposable (Class II - Special Controls, product code KDJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 10, 1987, 24 days after receiving the submission on March 17, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K871050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1987 |
| Decision Date | April 10, 1987 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KDJ — Set, Administration, For Peritoneal Dialysis, Disposable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |