Hicaliq Ivh Bag
FDA 510(k) K771432 · Terumo America, Inc.
510(k) numberK771432
Submission
- Device name
- Hicaliq Ivh Bag
- Applicant
- Terumo America, Inc.
Mchenry, IL, US - Received
- August 1, 1977
- Decision date
- September 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPE – Container, I.V.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5025
- Specialty
- General Hospital
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| K222622 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 02/16/2023SE |
| K210749 | Empty EVA BagKPE · Traditional | Haemotronic S.P.A. | 08/19/2021SE |
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLKPE · Traditional | Gilero, LLC | 05/06/2021SE |
More from Gilero, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K811523 | Plasma FlexKSR · Traditional | 09/09/1981SE |
| K802970 | Terumo Hollow Fiber OxygenatorDTZ · Traditional | 01/22/1981SE |
| K802441 | Clirans TH10 Hollow Fiber DialyzerFJI · Traditional | 12/18/1980SE |
| K802122 | Clirans TH13 Hollow Fiber DialyzerFJI · Traditional | 12/18/1980SE |
| K801194 | Clirans TE07 Hollow Fiber DialyzerFJI · Traditional | 08/12/1980SE |
| K801193 | Clirans TE15 Hollow Fiber DialyzerKDJ · Traditional | 08/12/1980SE |
| K801192 | Clirans TE10 Hollow Fiber DialyzerFJI · Traditional | 08/12/1980SE |
| K791411 | Coaxial Dual Flow CatheterKOC · Traditional | 11/13/1979SE |
| K791173 | Surflo Injection PlugFPA · Traditional | 07/30/1979SE |
| K790105 | Terumo ImugardGKT · Traditional | 05/24/1979SE |
Questions and answers
When was Hicaliq Ivh Bag cleared by the FDA?
Hicaliq Ivh Bag (K771432) received a 510(k) decision of Substantially Equivalent on September 28, 1977, 58 days after the submission was received.
What is the product code of K771432?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.