Red Color-Tinted Tubing

FDA 510(k) K832758 · Custom Medical, Inc.

Substantially Equivalent

510(k) numberK832758

Submission

Device name
Red Color-Tinted Tubing
Applicant
Custom Medical, Inc.
Mchenry, IL, US
Received
August 19, 1983
Decision date
September 12, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FPK – Tubing, Fluid Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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K031808Medrad Swabbable Valve Transfer SetFPK · Special Medrad, Inc.07/11/2003SE
K022431Medrad Transfer SetFPK · Traditional Medrad, Inc.09/05/2002SE
K965208Polyfin Extension Set, Models 126 and 128FPK · Traditional Medtronic Minimed02/26/1997SE
K953864Silclear Tubing (Modification)FPK · Traditional Degania Silicone , Ltd.11/06/1995SE
K950508Sysmex SF-3000FPK · Traditional Sysmex Corp.11/03/1995SE

More from Sysmex Corp.

510(k)DeviceDecision
K905002Single Use Manual ResuscitatorsBTM · Traditional 03/29/1991SE
K830182Custom IV SetFPA · Traditional 05/09/1983SE

Questions and answers

When was Red Color-Tinted Tubing cleared by the FDA?

Red Color-Tinted Tubing (K832758) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 24 days after the submission was received.

What is the product code of K832758?

The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.