K884322 is an FDA 510(k) clearance for the SUBCLAVIAN HEMODIALYSIS CATHETER. This device is classified as a Catheter, Subclavian (Class II - Special Controls, product code LFJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on April 25, 1989, 193 days after receiving the submission on October 14, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K884322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1988 |
| Decision Date | April 25, 1989 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LFJ — Catheter, Subclavian |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |