K854634 is an FDA 510(k) clearance for the BARD PARKER THORACIC VENT. This device is classified as a Bottle, Collection, Vacuum (Class II - Special Controls, product code KDQ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on December 27, 1985, 38 days after receiving the submission on November 19, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K854634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1985 |
| Decision Date | December 27, 1985 |
| Days to Decision | 38 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 |