Olympus Valvulotome W/Detachable Tip
FDA 510(k) K895878 · Olympus Corp.
510(k) numberK895878
Submission
- Device name
- Olympus Valvulotome W/Detachable Tip
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- October 5, 1989
- Decision date
- January 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K950813 | Mollring CutterDWX · Traditional | Cardio Vascular Concepts, Inc. | 07/25/1995SE |
| 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 |
| K894496 | Olympus Valvulotome W/Fixed TipDWX · Traditional | Olympus Corp. | 10/12/1989SE |
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| K915402 | EW-10 and EW-20FEB · Traditional | 06/23/1995SN |
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| K942338 | Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesFDT · Traditional | 11/30/1994SE |
| K931763 | Hf-Resection Electrode, Loop W/Runner Endos/AccessFAS · Traditional | 08/29/1994SE |
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Questions and answers
When was Olympus Valvulotome W/Detachable Tip cleared by the FDA?
Olympus Valvulotome W/Detachable Tip (K895878) received a 510(k) decision of Substantially Equivalent on January 2, 1990, 89 days after the submission was received.
What is the product code of K895878?
The FDA product code is DWX – Stripper, Artery, Intraluminal, a Class II (moderate risk) device regulated under 21 CFR 870.4875.