Secure-Site

FDA 510(k) K941098 · Op-Co Medical Products , Ltd.

Substantially Equivalent

510(k) numberK941098

Submission

Device name
Secure-Site
Applicant
Op-Co Medical Products , Ltd.
New York City, NY, US
Received
March 9, 1994
Decision date
August 9, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K981860A P HarnessKMK · Traditional Paraworks Enterprise, Ltd.06/03/1999SE
K963365Multi-Purpose Medical Tube HolderKMK · Traditional Byrd Medical Devices, Inc.10/11/1996SE
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

More from Menlo Care, Inc.

510(k)DeviceDecision
K932757Securodrip (TM) I.V. ArmboardKMK · Traditional 12/08/1993SE
K912660SecurodripKMK · Traditional 12/04/1991SE

Questions and answers

When was Secure-Site cleared by the FDA?

Secure-Site (K941098) received a 510(k) decision of Substantially Equivalent on August 9, 1995, 518 days after the submission was received.

What is the product code of K941098?

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