Peripheral Atherectomy System
FDA 510(k) K890515 · Intensive Technology, Inc.
510(k) numberK890515
Submission
- Device name
- Peripheral Atherectomy System
- Applicant
- Intensive Technology, Inc.
San Diego, CA, US - Received
- February 1, 1989
- Decision date
- May 23, 1989
- 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 |
| K895878 | Olympus Valvulotome W/Detachable TipDWX · Traditional | Olympus Corp. | 01/02/1990SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K922970 | Intra-Operative Tec Atherectomy SystemMCW · Traditional | 01/13/1993SE |
| K912664 | Tec Rotating Dual HemovalveDYB · Traditional | 08/24/1992SE |
| K911869 | Ivt Guiding CatheterDQY · Traditional | 10/16/1991SE |
| K903463 | Ivt Introducer SheathDYB · Traditional | 01/03/1991SE |
| K904003 | Hemochron(R) Heparin Response TestKFF · Traditional | 11/29/1990SE |
| K901767 | Modified Ivt Peripheral AtherectomyLIT · Traditional | 06/28/1990SE |
| K896403 | Modified Ivt Peripheral Atherectomy SystemLIT · Traditional | 03/06/1990SE |
| K895903 | Ivt 0.014 Guide WireDQX · Traditional | 01/04/1990SE |
| K892209 | Aptt by Hemochron(R)GFO · Traditional | 06/22/1989SE |
| K882804 | 0.014 Peripheral Guide WireDQX · Traditional | 10/28/1988SE |
Questions and answers
When was Peripheral Atherectomy System cleared by the FDA?
Peripheral Atherectomy System (K890515) received a 510(k) decision of Substantially Equivalent on May 23, 1989, 111 days after the submission was received.
What is the product code of K890515?
The FDA product code is DWX – Stripper, Artery, Intraluminal, a Class II (moderate risk) device regulated under 21 CFR 870.4875.