DQT

12 FDA 510(k) clearances · Product code

121 daysmedian time to decision

151 days90th percentile

12clearances measured

FDA profile

Official device name: Occluder, Catheter Tip
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1370
Medical specialty: Cardiovascular
Flags: Third-party review eligible
Adverse events (MAUDE): 2007: 3 · 2008: 5 · 2009: 2 · 2018: 12 · 2019: 21 · 2020: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Sort:Newest first Oldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

Record	Firm	Date
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT (K983927)	Arterial Vascular Engineering, Inc.	1999-03-11
THE OMNIGUIDE GUIDING CATHETER WITH BALLOON (K945963)	Micro Interventional Systems, Inc.	1995-02-08
CATHLAB SILICONE OCCLUSION BALLOON CATHETER (K910916)	Cathlab Corp.	1991-06-24
AVD INTIMAX OCCLUSION CATHETER (K910339)	Applied Vascular Devices, Inc.	1991-05-29
CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 (K880860)	Dlp, Inc.	1988-05-26
MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (K880231)	Ideas For Medicine, Inc.	1988-05-25
THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT (K872090)	Ideas For Medicine, Inc.	1987-10-30
PERFUSION CATHETER (K872790)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-09-15
MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH (K872154)	Ideas For Medicine, Inc.	1987-08-03
URESIL OCCLUSION BALLOON CATHETER (K863559)	Uresil Corp.	1986-10-10
OCCLUSION & OCCLUSION-IRRIGATION (K844918)	Clincal Instruments Corp.	1985-08-05
ACS SOF-T GUIDE WIREE (K840795)	Advanced Cardiovascular Systems, Inc.	1984-07-02

Track DQT automatically

Every clearance here is in the API, with alerts when new ones post.