K771432 is an FDA 510(k) clearance for the HICALIQ IVH BAG. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1977, 58 days after receiving the submission on August 1, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K771432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1977 |
| Decision Date | September 28, 1977 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |