K881449 is an FDA 510(k) clearance for the EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116. This device is classified as a Probe, Test, Heart-valve (Class I - General Controls, product code LXN).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 15, 1988, 71 days after receiving the submission on April 5, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.
| 510(k) Number | K881449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1988 |
| Decision Date | June 15, 1988 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | LXN — Probe, Test, Heart-valve |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |