Phaseal Protector P14, P21, P28 and P50
FDA 510(k) K090634 · Carmel Pharma Ab.
510(k) numberK090634
Submission
- Device name
- Phaseal Protector P14, P21, P28 and P50
- Applicant
- Carmel Pharma Ab.
Gothenburg, SE - Received
- March 9, 2009
- Decision date
- March 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | Yukon Medical, LLC | 03/21/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | Icu Medical, Inc. | 01/22/2025SE |
| K243486 | SmartSiteTM Vented Vial Access DeviceLHI · Traditional | Yukon Medical, LLC | 12/06/2024SE |
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More from Sfm Medical Devices GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K110023 | Infusion Adapter C100LHI · Traditional | 04/12/2011SE |
| K092782 | Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…LHI · Traditional | 12/07/2009SE |
| K060866 | Phaseal - Closed System for the Preparation and Administration of Parenteral DrugsLHI · Special | 04/28/2006SE |
| K023747 | PhasealLHI · Special | 11/15/2002SE |
| K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion AdapterLHI · Special | 05/12/2000SE |
| K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…LHI · Traditional | 03/03/1998SE |
Questions and answers
When was Phaseal Protector P14, P21, P28 and P50 cleared by the FDA?
Phaseal Protector P14, P21, P28 and P50 (K090634) received a 510(k) decision of Substantially Equivalent on March 23, 2009, 14 days after the submission was received.
What is the product code of K090634?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.