GT1 Floppy, GT1 Hi-Per Flex, GT1 Light Support

FDA 510(k) K983927 · Arterial Vascular Engineering, Inc.

Substantially Equivalent

510(k) numberK983927

Submission

Device name
GT1 Floppy, GT1 Hi-Per Flex, GT1 Light Support
Applicant
Arterial Vascular Engineering, Inc.
Billerica, MA, US
Received
November 5, 1998
Decision date
March 11, 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
DQT – Occluder, Catheter Tip
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1370
Specialty
Cardiovascular

Other 510(k)s with product code DQT

510(k)DeviceApplicantDecision
K945963The Omniguide Guiding Catheter with BalloonDQT · Traditional Micro Interventional Systems, Inc.02/08/1995SE
K910916Cathlab Silicone Occlusion Balloon CatheterDQT · Traditional Cathlab Corp.06/24/1991SE
K910339Avd Intimax Occlusion CatheterDQT · Traditional Applied Vascular Devices, Inc.05/29/1991SE
K880860Coronary Ostium Occluder, Catalog Code 32015DQT · Traditional Dlp, Inc.05/26/1988SE
K880231Modified Pruitt Irrigation & Occlusion CatheterDQT · Traditional Ideas For Medicine, Inc.05/25/1988SE
K872090The Robicsek - Pruitt Aortic Balloon Occlusion KitDQT · Traditional Ideas For Medicine, Inc.10/30/1987SE
K872790Perfusion CatheterDQT · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic09/15/1987SE
K872154Modified Info Inserts for Pruitt Irri.-Occlu. CathDQT · Traditional Ideas For Medicine, Inc.08/03/1987SE
K863559Uresil Occlusion Balloon CatheterDQT · Traditional Uresil Corp.10/10/1986SE
K844918Occlusion & Occlusion-IrrigationDQT · Traditional Clincal Instruments Corp.08/05/1985SE

More from Clincal Instruments Corp.

510(k)DeviceDecision
K984627Ave 4F Siteseer Cardiovascular Angiographic CatheterDQO · Traditional 07/27/1999SE
K971295Ave Bridge Stent SystemFGE · Traditional 11/05/1997SE

Questions and answers

When was GT1 Floppy, GT1 Hi-Per Flex, GT1 Light Support cleared by the FDA?

GT1 Floppy, GT1 Hi-Per Flex, GT1 Light Support (K983927) received a 510(k) decision of Substantially Equivalent on March 11, 1999, 126 days after the submission was received.

What is the product code of K983927?

The FDA product code is DQT – Occluder, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.1370.