Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520
FDA 510(k) K022823 · Geister Medizin Technik GmbH
510(k) numberK022823
Submission
- Device name
- Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520
- Applicant
- Geister Medizin Technik GmbH
Hot Springs, NC, US - Received
- August 26, 2002
- Decision date
- July 1, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K221902 | LimFlow VectorMGZ · Traditional | LimFlow, Inc. | 12/21/2022SE |
| K190267 | EZE SIT ValvulotomeMGZ · Traditional | Lemaitre Vascular | 10/30/2019SE |
| K142660 | Antegrade LeMills ValvulotomeMGZ · Special | LeMaitre Vascular, Inc. | 10/17/2014SE |
| K140042 | 1.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 04/10/2014SE |
| 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 |
| K080178 | Valvulotome by KovenMGZ · Traditional | Koven Technology, Inc. | 07/28/2008SE |
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| K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel DilatorsDWP · Traditional | 07/12/2003SE |
| K982365 | Atraumatic Vascular Clamps, Model #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX Micro Vascular…DXC · Traditional | 04/08/1999SE |
| K933699 | Geister Surgical Int'L Bipolar Endoscopic Surgical InstrumentsGEI · Traditional | 01/27/1994SE |
Questions and answers
When was Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520 cleared by the FDA?
Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520 (K022823) received a 510(k) decision of Substantially Equivalent on July 1, 2004, 675 days after the submission was received.
What is the product code of K022823?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.