K770720 is an FDA 510(k) clearance for the TUBING PACK, EXTRACORPOREAL, H-3000. This device is classified as a Oxygenator, Long Term Support Greater Than 6 Hours (Class II - Special Controls, product code BYS).
Submitted by William Harvey Life Products Corp. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977, 108 days after receiving the submission on April 18, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4100.
| 510(k) Number | K770720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 1977 |
| Decision Date | August 04, 1977 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | BYS — Oxygenator, Long Term Support Greater Than 6 Hours |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4100 |