K920907 is an FDA 510(k) clearance for the OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Teleflexmedical, Inc. (Jeffrey, US). The FDA issued a Cleared decision on October 6, 1992, 222 days after receiving the submission on February 27, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K920907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1992 |
| Decision Date | October 06, 1992 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |