Mollring Cutter
FDA 510(k) K950813 · Cardio Vascular Concepts, Inc.
510(k) numberK950813
Submission
- Device name
- Mollring Cutter
- Applicant
- Cardio Vascular Concepts, Inc.
Portola Valley, CA, US - Received
- February 22, 1995
- Decision date
- July 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWX – Stripper, Artery, Intraluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
Other 510(k)s with product code DWX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121415 | Mollring MultitascDWX · Traditional | LeMaitre Vascular, Inc. | 09/05/2012SE |
| K032105 | Endohelix Endarterectomy DeviceDWX · Traditional | Endarx, Inc. | 10/30/2003SE |
| K020925 | Carbodissecting EndoscopeDWX · Traditional | Endo Surgical Devices, Inc. | 04/29/2003SE |
| K003719 | Vascular Architects Periscope DeviceDWX · Traditional | Vascular Architects, Inc. | 02/28/2001SE |
| K933498 | External Vein StripperDWX · Traditional | Applied Medical Resources | 03/23/1994SE |
| K913803 | Intraluminal Artery StripperDWX · Traditional | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 04/24/1992SE |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | Pilling Co. | 06/25/1991SE |
| K904944 | Transluminal Endarterectomy DeviceDWX · Traditional | Baxter Healthcare Corp | 12/17/1990SE |
| K895878 | Olympus Valvulotome W/Detachable TipDWX · Traditional | Olympus Corp. | 01/02/1990SE |
| K894496 | Olympus Valvulotome W/Fixed TipDWX · Traditional | Olympus Corp. | 10/12/1989SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K950155 | Rapid-Trak(Tm) Introducer SheathDYB · Traditional | 08/02/1995SE |
Questions and answers
When was Mollring Cutter cleared by the FDA?
Mollring Cutter (K950813) received a 510(k) decision of Substantially Equivalent on July 25, 1995, 153 days after the submission was received.
What is the product code of K950813?
The FDA product code is DWX – Stripper, Artery, Intraluminal, a Class II (moderate risk) device regulated under 21 CFR 870.4875.