K803300 is an FDA 510(k) clearance for the INPERSOL CAPD BAG PORT CLAMP. 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 January 29, 1981, 30 days after receiving the submission on December 30, 1980.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K803300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1980 |
| Decision Date | January 29, 1981 |
| Days to Decision | 30 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 |