LogoFDA 510(k) Search
K Number
K963365
Device Name
MULTI-PURPOSE MEDICAL TUBE HOLDER
Manufacturer
BYRD MEDICAL DEVICES, INC.
Date Cleared
1996-10-11

(45 days)

Product Code
KMK
Regulation Number
880.5210
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 880.5210 Intravascular catheter securement device.

(a)
Identification. An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.