K934782 is an FDA 510(k) clearance for the AMMEX TUBING ORGANIZER. This device is classified as a Accessory Equipment, Cardiopulmonary Bypass (Class I - General Controls, product code KRI).
Submitted by Ammex Cardiopulmonary Corp. (Houston, US). The FDA issued a Cleared decision on November 18, 1993, 43 days after receiving the submission on October 6, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4200.
| 510(k) Number | K934782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1993 |
| Decision Date | November 18, 1993 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | KRI — Accessory Equipment, Cardiopulmonary Bypass |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4200 |