Intravascular Catheter Securement Dev

FDA 510(k) K841487 · Tapemark Co.

Substantially Equivalent

510(k) numberK841487

Submission

Device name
Intravascular Catheter Securement Dev
Applicant
Tapemark Co.
Mchenry, IL, US
Received
April 10, 1984
Decision date
June 28, 1984
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

Questions and answers

When was Intravascular Catheter Securement Dev cleared by the FDA?

Intravascular Catheter Securement Dev (K841487) received a 510(k) decision of Substantially Equivalent on June 28, 1984, 79 days after the submission was received.

What is the product code of K841487?

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