Primary Piggyback Infusion Set W/Perm

Q: What is the product code of K833682?

The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.

FDA 510(k) K833682 · Cosmetic Sciences, Inc.

Substantially Equivalent

510(k) numberK833682

Submission

Device name: Primary Piggyback Infusion Set W/Perm
Applicant: Cosmetic Sciences, Inc.
Mchenry, IL, US
Received: October 31, 1983
Decision date: November 28, 1983
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LDR – Controller, Infusion, Intravascular, Electronic
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5725
Specialty: General Hospital

Other 510(k)s with product code LDR

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K232316	DEKA Infusion System, DEKA Administration SetLDR · Traditional	Deka Research and Development	03/01/2024SE
K153760	Volumetric Infusion ControllerLDR · Traditional	DEKA Research & Development	10/03/2016SE
K963136	Pacer Model 100 Infusion ControllerLDR · Traditional	Health Watch, Inc.	10/10/1997SE
K971865	Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500-3PLDR · Traditional	Alexander Mfg. Co.	07/03/1997SE
K971826	Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500LDR · Traditional	Alexander Mfg. Co.	07/03/1997SE
K934543	Universal Controller, Model 100LDR · Traditional	Metamed, Inc.	03/29/1994SE
K935236	Flow Controlling Extension SetLDR · Traditional	Block Medical, Inc.	02/24/1994SE
K905498	Stat 2 IV PumpetteLDR · Traditional	The Master Medical Corp.	04/16/1991SE
K905497	Master Flow I.V. PumpetteLDR · Traditional	The Master Medical Corp.	04/16/1991SE

More from The Master Medical Corp.

510(k)	Device	Decision
K842756	Butterfly II PN Infusion NeedleFMI · Traditional	07/23/1984SE
K830568	Guttman Infusion NeedleFMI · Traditional	10/27/1983SE
K822603	Perma-Set Infusion SetLDR · Traditional	09/14/1982SE

Questions and answers

When was Primary Piggyback Infusion Set W/Perm cleared by the FDA?

Primary Piggyback Infusion Set W/Perm (K833682) received a 510(k) decision of Substantially Equivalent on November 28, 1983, 28 days after the submission was received.

What is the product code of K833682?

The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.