K875188 is an FDA 510(k) clearance for the LUER LOCK CONNECTORS / RIDIG P.V.C.. This device is classified as a Catheter, Subclavian (Class II - Special Controls, product code LFJ).
Submitted by Vas-Cath of Canada , Ltd. (Ontario, L5a 3v3, CA). The FDA issued a Cleared decision on March 2, 1988, 76 days after receiving the submission on December 17, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K875188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1987 |
| Decision Date | March 02, 1988 |
| Days to Decision | 76 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 |