DWX · Stripper, Artery, Intraluminal
Cardiovascular · 21 CFR 870.4875 · Class 2
Overview
| Product Code | DWX |
|---|---|
| Device Name | Stripper, Artery, Intraluminal |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121415 | MOLLRING MULTITASC | LeMaitre Vascular, Inc. | Sep 5, 2012 | SESE |
| K032105 | ENDOHELIX ENDARTERECTOMY DEVICE | Endarx, Inc. | Oct 30, 2003 | SESE |
| K020925 | CARBODISSECTING ENDOSCOPE | Endo Surgical Devices, Inc. | Apr 29, 2003 | SESE |
| K003719 | VASCULAR ARCHITECTS PERISCOPE DEVICE | Vascular Architects, Inc. | Feb 28, 2001 | SESE |
| K950813 | MOLLRING CUTTER | Cardio Vascular Concepts, Inc. | Jul 25, 1995 | SESE |
| K933498 | EXTERNAL VEIN STRIPPER | Applied Medical Resources | Mar 23, 1994 | SESE |
| K913803 | INTRALUMINAL ARTERY STRIPPER | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | Apr 24, 1992 | SESE |
| K911099 | MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE | Pilling Co. | Jun 25, 1991 | SESE |
| K904944 | TRANSLUMINAL ENDARTERECTOMY DEVICE | Baxter Healthcare Corp | Dec 17, 1990 | SESE |
| K895878 | OLYMPUS VALVULOTOME W/DETACHABLE TIP | Olympus Corp. | Jan 2, 1990 | SESE |
| K894496 | OLYMPUS VALVULOTOME W/FIXED TIP | Olympus Corp. | Oct 12, 1989 | SESE |
| K890515 | PERIPHERAL ATHERECTOMY SYSTEM | Intensive Technology, Inc. | May 23, 1989 | SESE |
| K841521 | SCANLAN ENDARSECTOR | Scanlan Intl., Inc. | Aug 3, 1984 | SESE |
| K801063 | HALL ARTERIAL OSCILLATOR | American Sterilizer Co. | Sep 26, 1980 | SESE |
Top Applicants
- Olympus Corp. — 2 clearances
- Vascular Architects, Inc. — 1 clearance
- Scanlan Intl., Inc. — 1 clearance
- Pilling Co. — 1 clearance
- Omni-Tract Surgical, Div. Minn. Scientific, Inc. — 1 clearance
