Primary IV Set
FDA 510(k) K964435 · Icu Medical, Inc.
510(k) numberK964435
Submission
- Device name
- Primary IV Set
- Applicant
- Icu Medical, Inc.
San Clemente, CA, US - Received
- November 5, 1996
- Decision date
- April 2, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMG – Stopcock, I.V. Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal…FMG · Traditional | Monumedical, LLC | 10/22/2019SE |
| K190489 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 04/23/2019SE |
| K172266 | Dynarex Three-Way StopcockFMG · Traditional | Dynarex Corporation | 03/14/2018SE |
| K141254 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 07/30/2014SE |
| K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…FMG · Traditional | Elcam Medical Acal | 05/23/2013SE |
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| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | 04/02/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | 01/22/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | 12/20/2023SE |
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Questions and answers
When was Primary IV Set cleared by the FDA?
Primary IV Set (K964435) received a 510(k) decision of Substantially Equivalent on April 2, 1997, 148 days after the submission was received.
What is the product code of K964435?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.