K893439 is an FDA 510(k) clearance for the HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C. This device is classified as a Catheter, Subclavian (Class II - Special Controls, product code LFJ).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on June 13, 1989, 41 days after receiving the submission on May 3, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K893439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1989 |
| Decision Date | June 13, 1989 |
| Days to Decision | 41 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 |