Valvulotome by Koven
FDA 510(k) K080178 · Koven Technology, Inc.
510(k) numberK080178
Submission
- Device name
- Valvulotome by Koven
- Applicant
- Koven Technology, Inc.
Houston, TX, US - Received
- January 24, 2008
- Decision date
- July 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGZ – Valvulotome
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
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| K132047 | Lemills ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 11/05/2013SE |
| K132190 | Expandable Lemaitre Valvulotome, Over-The-Wire Lemaitre ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 08/05/2013SE |
| K111884 | Over-The-Wire Expandable Lemaitre ValvulotomeMGZ · Special | LeMaitre Vascular, Inc. | 07/29/2011SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K201114 | Bidop 7DPW · Traditional | 01/05/2021SE |
| K153762 | Smartdop XT6JOP · Traditional | 05/25/2016SE |
| K143332 | Fast Sphyg by KovenDXQ · Traditional | 04/14/2015SE |
| K131623 | Smartdop XTJOP · Traditional | 01/17/2014SE |
| K050601 | Smartdop 45 Vascular DopplerDPW · Traditional | 04/15/2005SE |
| K031931 | Echo Sounder EX-101EX 8 MHZDPW · Traditional | 02/13/2004SE |
| K031504 | Echo Sounder, Single-Handed, Model ES-101EXKNG · Traditional | 07/18/2003SE |
| K023143 | Echo Sounder, ES-102EXKNG · Traditional | 12/19/2002SE |
| K010452 | Bi-Directional Doppler Volume Flowmeter, Model DVM-4300 & 4300TDPW · Traditional | 02/12/2002SE |
| K982986 | Tubing Blood Flow Meter Model Number HD-800DPW · Traditional | 11/24/1998SE |
Questions and answers
When was Valvulotome by Koven cleared by the FDA?
Valvulotome by Koven (K080178) received a 510(k) decision of Substantially Equivalent on July 28, 2008, 186 days after the submission was received.
What is the product code of K080178?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.