IV Band (Intravenous Catheter Assesory)

FDA 510(k) K860706 · T. G. & E. Medical

Substantially Equivalent

510(k) numberK860706

Submission

Device name
IV Band (Intravenous Catheter Assesory)
Applicant
T. G. & E. Medical
Boise, ID, US
Received
February 26, 1986
Decision date
March 21, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KMK – Device, Intravascular Catheter Securement
Device class
Class I (low risk)
Regulation
21 CFR 880.5210
Specialty
General Hospital

Other 510(k)s with product code KMK

510(k)DeviceApplicantDecision
K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…KMK · Traditional Interrad Medical, Inc.07/09/2019SE
K981860A P HarnessKMK · Traditional Paraworks Enterprise, Ltd.06/03/1999SE
K963365Multi-Purpose Medical Tube HolderKMK · Traditional Byrd Medical Devices, Inc.10/11/1996SE
K941098Secure-SiteKMK · Traditional Op-Co Medical Products , Ltd.08/09/1995SE
K943147Statlock CVKMK · Traditional Venetec, Inc.09/29/1994SE
K943047IV Start KitsKMK · Traditional Sterile Concepts, Inc.09/14/1994SE
K941940Immobile Sterile and Immobile A/C SterileKMK · Traditional Tnt Moborg Intl. , Ltd.07/14/1994SE
K941850Immobile Non-Sterile and Immobile A/C Non-SterileKMK · Traditional Tnt Moborg Intl. , Ltd.07/14/1994SE
K935389Conmed Veni-Gard I.V. DressingKMK · Traditional Conmedcorp03/07/1994SE
K935252K-Lok Catheter Securement Device ModificationKMK · Traditional K-Lok, Inc.02/18/1994SE

More from K-Lok, Inc.

510(k)DeviceDecision
K860261Cannula BandCAT · Traditional 02/18/1986SE
K823221Acca-Temp Skin Temp. Vinyl DiscKPD · Traditional 01/12/1983SE
K820941Therma-Scan · Traditional 06/16/1982SE
K813199Skin Temperature Sensing Vinyl StripKPD · Traditional 03/05/1982SE

Questions and answers

When was IV Band (Intravenous Catheter Assesory) cleared by the FDA?

IV Band (Intravenous Catheter Assesory) (K860706) received a 510(k) decision of Substantially Equivalent on March 21, 1986, 23 days after the submission was received.

What is the product code of K860706?

The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.