K920634 is an FDA 510(k) clearance for the SPLITTABLE SHEATH INTRODUCER SET, a Catheter, Subclavian (Class II — Special Controls, product code LFJ), submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on January 14, 1994, 702 days after receiving the submission on February 12, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K920634 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 12, 1992 |
| Decision Date | January 14, 1994 |
| Days to Decision | 702 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LFJ — Catheter, Subclavian |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |