K771594 is an FDA 510(k) clearance for the PRIMARY PIGGYBACK VENOSET W/ FILTER. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 28, 1977, 40 days after receiving the submission on August 19, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K771594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1977 |
| Decision Date | September 28, 1977 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |