K871850 is an FDA 510(k) clearance for the TELEFLEX STEERABLE GUIDEWIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Teleflexmedical, Inc. (Jeffrey, US). The FDA issued a Cleared decision on January 27, 1988, 260 days after receiving the submission on May 12, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K871850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1987 |
| Decision Date | January 27, 1988 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |