K915423 is an FDA 510(k) clearance for the HEMO-CATH SILICONE ACCESS CATHETER. 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 February 2, 1993, 428 days after receiving the submission on December 2, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K915423 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 02, 1991 |
| Decision Date | February 02, 1993 |
| Days to Decision | 428 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LFJ — Catheter, Subclavian |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |