K823135 is an FDA 510(k) clearance for the DOUBLE LUMEN SUBCLAVIAN CATHETER. This device is classified as a Catheter, Subclavian (Class II - Special Controls, product code LFJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 7, 1983, 130 days after receiving the submission on October 28, 1982.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K823135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1982 |
| Decision Date | March 07, 1983 |
| Days to Decision | 130 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 |