Guarded Luer Connector
FDA 510(k) K173577 · International Medical Industries, Inc.
510(k) numberK173577
Submission
- Device name
- Guarded Luer Connector
- Applicant
- International Medical Industries, Inc.
Pompano Beach, FL, US - Received
- November 20, 2017
- Decision date
- June 7, 2018
- 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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| K241976 | nextaro® va, 15mm, 5µmLHI · Special | Sfm Medical Devices GmbH | 09/06/2024SE |
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Questions and answers
When was Guarded Luer Connector cleared by the FDA?
Guarded Luer Connector (K173577) received a 510(k) decision of Substantially Equivalent on June 7, 2018, 199 days after the submission was received.
What is the product code of K173577?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.