K910421 is an FDA 510(k) clearance for the SATURATION/HEMATOCRIT MONITOR SYSTEM. This device is classified as a Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (Class II - Special Controls, product code DRY).
Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on October 15, 1991, 258 days after receiving the submission on January 30, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4330.
| 510(k) Number | K910421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1991 |
| Decision Date | October 15, 1991 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRY — Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4330 |