K895014 is an FDA 510(k) clearance for the BAXTER BAFFLED TEE ADAPTER. This device is classified as a Connector, Airway (extension) (Class I - General Controls, product code BZA).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on October 30, 1989, 83 days after receiving the submission on August 8, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5810.
| 510(k) Number | K895014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1989 |
| Decision Date | October 30, 1989 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZA — Connector, Airway (extension) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5810 |