Stripper, Artery, Intraluminal
The Intraluminal Artery Stripper is a cardiovascular surgical instrument introduced into the lumen of an artery to remove atherosclerotic plaques or to assist in vessel removal during vascular reconstruction procedures such as endarterectomy. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWX and it is regulated under 21 CFR 870.4875 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DWX
- Device Class
- FDA class 2
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K121415 | MOLLRING MULTITASC | Sep 05, 2012 | Substantially Equivalent | LeMaitre Vascular, Inc. |
| K032105 | ENDOHELIX ENDARTERECTOMY DEVICE | Oct 30, 2003 | Substantially Equivalent | Endarx, Inc. |
| K020925 | CARBODISSECTING ENDOSCOPE | Apr 29, 2003 | Substantially Equivalent | Endo Surgical Devices, Inc. |
| K003719 | VASCULAR ARCHITECTS PERISCOPE DEVICE | Feb 28, 2001 | Substantially Equivalent | Vascular Architects, Inc. |
| K950813 | MOLLRING CUTTER | Jul 25, 1995 | Substantially Equivalent | Cardio Vascular Concepts, Inc. |
| K933498 | EXTERNAL VEIN STRIPPER | Mar 23, 1994 | Substantially Equivalent | Applied Medical Resources |
| K913803 | INTRALUMINAL ARTERY STRIPPER | Apr 24, 1992 | Substantially Equivalent | Omni-Tract Surgical, Div. Minn. Scientific, Inc. |
| K911099 | MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE | Jun 25, 1991 | Substantially Equivalent | Pilling Co. |
| K904944 | TRANSLUMINAL ENDARTERECTOMY DEVICE | Dec 17, 1990 | Substantially Equivalent | Baxter Healthcare Corp |
| K895878 | OLYMPUS VALVULOTOME W/DETACHABLE TIP | Jan 02, 1990 | Substantially Equivalent | Olympus Corp. |
| K894496 | OLYMPUS VALVULOTOME W/FIXED TIP | Oct 12, 1989 | Substantially Equivalent | Olympus Corp. |
| K890515 | PERIPHERAL ATHERECTOMY SYSTEM | May 23, 1989 | Substantially Equivalent | Intensive Technology, Inc. |
| K841521 | SCANLAN ENDARSECTOR | Aug 03, 1984 | Substantially Equivalent | Scanlan Intl., Inc. |
| K801063 | HALL ARTERIAL OSCILLATOR | Sep 26, 1980 | Substantially Equivalent | American Sterilizer Co. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.