Excelsior Single Lead Dispensing Set

Q: What is the product code of K913804?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.

FDA 510(k) K913804 · Excel Medical, Inc.

Substantially Equivalent

510(k) numberK913804

Submission

Device name: Excelsior Single Lead Dispensing Set
Applicant: Excel Medical, Inc.
Asbury Park, NJ, US
Received: August 26, 1991
Decision date: February 11, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: LHI – Set, I.V. Fluid Transfer
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5440
Specialty: General Hospital

Other 510(k)s with product code LHI

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K243404	HyHub and HyHub Duo Vial Access DevicesLHI · Traditional	Takeda Pharmaceuticals	07/18/2025SE
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
K241976	nextaro® va, 15mm, 5µmLHI · Special	Sfm Medical Devices GmbH	09/06/2024SE

More from Sfm Medical Devices GmbH

510(k)	Device	Decision
K932462	Vented NeedleLHI · Traditional	09/15/1993SE
K923966	Syringe AdaptorLHI · Traditional	06/18/1993SE
K914988	500 InfuserFRN · Traditional	04/06/1992SE
K905116	Pharm-AssistLHI · Traditional	04/25/1991SE

Questions and answers

When was Excelsior Single Lead Dispensing Set cleared by the FDA?

Excelsior Single Lead Dispensing Set (K913804) received a 510(k) decision of Substantially Equivalent on February 11, 1992, 169 days after the submission was received.

What is the product code of K913804?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.