Tevadaptor, Closed Drug Reconstitution and Transfer System
FDA 510(k) K071741 · Migada Plant
510(k) numberK071741
Submission
- Device name
- Tevadaptor, Closed Drug Reconstitution and Transfer System
- Applicant
- Migada Plant
Kiryat Shmona, IL - Received
- June 27, 2007
- Decision date
- September 24, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
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Questions and answers
When was Tevadaptor, Closed Drug Reconstitution and Transfer System cleared by the FDA?
Tevadaptor, Closed Drug Reconstitution and Transfer System (K071741) received a 510(k) decision of Substantially Equivalent on September 24, 2007, 89 days after the submission was received.
What is the product code of K071741?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.