Vein-Shield

FDA 510(k) K820759 · Pan-Tech Research, Inc.

Substantially Equivalent

510(k) numberK820759

Submission

Device name
Vein-Shield
Applicant
Pan-Tech Research, Inc.
Walker, MI, US
Received
March 22, 1982
Decision date
May 14, 1982
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

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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.

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Questions and answers

When was Vein-Shield cleared by the FDA?

Vein-Shield (K820759) received a 510(k) decision of Substantially Equivalent on May 14, 1982, 53 days after the submission was received.

What is the product code of K820759?

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