K913468 is an FDA 510(k) clearance for the ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY, a Catheter, Subclavian (Class II — Special Controls, product code LFJ), submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on March 24, 1994, 962 days after receiving the submission on August 5, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K913468 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 05, 1991 |
| Decision Date | March 24, 1994 |
| Days to Decision | 962 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LFJ — Catheter, Subclavian |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |