Product code DQT— Cardiovascular

FDA has cleared 12 devices under product code DQT between 1984 and 1999, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19991 clearance
• 19951 clearance
• 19912 clearances
• 19882 clearances
• 19873 clearances
• 19861 clearance
• 19851 clearance
• 19841 clearance

• Ideas For Medicine, Inc.3 clearances
• Uresil Corp.1 clearance
• Micro Interventional Systems, Inc.1 clearance
• Dlp, Inc.1 clearance
• Clincal Instruments Corp.1 clearance
• Cathlab Corp.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• Arterial Vascular Engineering, Inc.1 clearance
• Applied Vascular Devices, Inc.1 clearance
• Advanced Cardiovascular Systems, Inc.1 clearance

• K983927 — GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORTArterial Vascular Engineering, Inc.·1999-03-11
• K945963 — THE OMNIGUIDE GUIDING CATHETER WITH BALLOONMicro Interventional Systems, Inc.·1995-02-08
• K910916 — CATHLAB SILICONE OCCLUSION BALLOON CATHETERCathlab Corp.·1991-06-24
• K910339 — AVD INTIMAX OCCLUSION CATHETERApplied Vascular Devices, Inc.·1991-05-29
• K880860 — CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015Dlp, Inc.·1988-05-26
• K880231 — MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETERIdeas For Medicine, Inc.·1988-05-25
• K872090 — THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KITIdeas For Medicine, Inc.·1987-10-30
• K872790 — PERFUSION CATHETERBd Becton Dickinson Vacutainer Systems Preanalytic·1987-09-15
• K872154 — MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATHIdeas For Medicine, Inc.·1987-08-03
• K863559 — URESIL OCCLUSION BALLOON CATHETERUresil Corp.·1986-10-10
• K844918 — OCCLUSION & OCCLUSION-IRRIGATIONClincal Instruments Corp.·1985-08-05
• K840795 — ACS SOF-T GUIDE WIREEAdvanced Cardiovascular Systems, Inc.·1984-07-02