K861025 is an FDA 510(k) clearance for the T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES. This device is classified as a Bottle, Collection, Vacuum (Class II - Special Controls, product code KDQ).
Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on April 28, 1986, 41 days after receiving the submission on March 18, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K861025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1986 |
| Decision Date | April 28, 1986 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KDQ — Bottle, Collection, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |