K841296 is an FDA 510(k) clearance for the TUBE TENDER. This device is classified as a Accessory Equipment, Cardiopulmonary Bypass (Class I - General Controls, product code KRI).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1984, 73 days after receiving the submission on March 30, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4200.
| 510(k) Number | K841296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1984 |
| Decision Date | June 11, 1984 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRI — Accessory Equipment, Cardiopulmonary Bypass |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4200 |