A P Harness

FDA 510(k) K981860 · Paraworks Enterprise, Ltd.

Substantially Equivalent

510(k) numberK981860

Submission

Device name
A P Harness
Applicant
Paraworks Enterprise, Ltd.
Vancouver, British Columbia, CA
Received
May 27, 1998
Decision date
June 3, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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
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
K940127Centermark Securing WingsKMK · Traditional Menlo Care, Inc.02/09/1994SE

Questions and answers

When was A P Harness cleared by the FDA?

A P Harness (K981860) received a 510(k) decision of Substantially Equivalent on June 3, 1999, 372 days after the submission was received.

What is the product code of K981860?

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