Vascular Architects Periscope Device
FDA 510(k) K003719 · Vascular Architects, Inc.
510(k) numberK003719
Submission
- Device name
- Vascular Architects Periscope Device
- Applicant
- Vascular Architects, Inc.
San Jose, CA, US - Received
- December 4, 2000
- Decision date
- February 28, 2001
- 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
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| 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 |
| 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 |
| 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 |
|---|---|---|
| K031641 | Vascular Architects Aspire Covered Stent and 718 Delivery SystemJCT · Traditional | 08/01/2003SE |
| K030567 | Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion…JCT · Special | 03/24/2003SE |
| K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemJCT · Traditional | 11/15/2001SE |
| K003173 | Aspire Covered Stent and Delivery CatheterESW · Traditional | 03/13/2001SE |
Questions and answers
When was Vascular Architects Periscope Device cleared by the FDA?
Vascular Architects Periscope Device (K003719) received a 510(k) decision of Substantially Equivalent on February 28, 2001, 86 days after the submission was received.
What is the product code of K003719?
The FDA product code is DWX – Stripper, Artery, Intraluminal, a Class II (moderate risk) device regulated under 21 CFR 870.4875.