K070414 is an FDA 510(k) clearance for the GAMBRO CARTRIDGE BLOOD SETS, a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on October 12, 2007, 242 days after receiving the submission on February 12, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K070414 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 12, 2007 |
| Decision Date | October 12, 2007 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |