K934803 is an FDA 510(k) clearance for the ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS. This device is classified as a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II - Special Controls, product code FJK).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on December 17, 1993, 58 days after receiving the submission on October 20, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K934803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1993 |
| Decision Date | December 17, 1993 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |