K993268 is an FDA 510(k) clearance for the MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Mallinckrodt Dar S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on April 19, 2000, 202 days after receiving the submission on September 30, 1999.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K993268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1999 |
| Decision Date | April 19, 2000 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |