DWX

14 FDA 510(k) clearances · Product code

114 daysmedian time to decision

247 days90th percentile

14clearances measured

FDA profile

Official device name: Stripper, Artery, Intraluminal
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.4875
Medical specialty: Cardiovascular
Flags: Third-party review eligible
Adverse events (MAUDE): 2008: 2
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
MOLLRING MULTITASC (K121415)	LeMaitre Vascular, Inc.	2012-09-05
ENDOHELIX ENDARTERECTOMY DEVICE (K032105)	Endarx, Inc.	2003-10-30
CARBODISSECTING ENDOSCOPE (K020925)	Endo Surgical Devices, Inc.	2003-04-29
VASCULAR ARCHITECTS PERISCOPE DEVICE (K003719)	Vascular Architects, Inc.	2001-02-28
MOLLRING CUTTER (K950813)	Cardio Vascular Concepts, Inc.	1995-07-25
EXTERNAL VEIN STRIPPER (K933498)	Applied Medical Resources	1994-03-23
INTRALUMINAL ARTERY STRIPPER (K913803)	Omni-Tract Surgical, Div. Minn. Scientific, Inc.	1992-04-24
MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (K911099)	Pilling Co.	1991-06-25
TRANSLUMINAL ENDARTERECTOMY DEVICE (K904944)	Baxter Healthcare Corp	1990-12-17
OLYMPUS VALVULOTOME W/DETACHABLE TIP (K895878)	Olympus Corp.	1990-01-02
OLYMPUS VALVULOTOME W/FIXED TIP (K894496)	Olympus Corp.	1989-10-12
PERIPHERAL ATHERECTOMY SYSTEM (K890515)	Intensive Technology, Inc.	1989-05-23
SCANLAN ENDARSECTOR (K841521)	Scanlan Intl., Inc.	1984-08-03
HALL ARTERIAL OSCILLATOR (K801063)	American Sterilizer Co.	1980-09-26

Track DWX automatically

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