Optical Valvulotome
FDA 510(k) K914385 · Intramed Laboratories, Inc.
510(k) numberK914385
Submission
- Device name
- Optical Valvulotome
- Applicant
- Intramed Laboratories, Inc.
San Diego, CA, US - Received
- October 1, 1991
- Decision date
- March 2, 1992
- 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 |
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| K132047 | Lemills ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 11/05/2013SE |
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| 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 |
More from Koven Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953258 | Titanium Hemostatic ClipFZP · Traditional | 01/05/1996SE |
| K942457 | Graft Thrombectomy InstrumentsMCW · Traditional | 02/07/1995SE |
| K931792 | ArthroscopeHRH · Traditional | 06/13/1994SE |
| K925283 | ValvulotomeMGZ · Traditional | 02/10/1994SE |
| K934696 | AngioscopeLYK · Traditional | 01/18/1994SE |
| K922114 | Endoscopic Retrieval BasketFFL · Traditional | 08/03/1992SE |
| K904465 | Flexible ArthroscopeHRX · Traditional | 12/20/1990SE |
| K903528 | LaparoscopeHET · Traditional | 09/04/1990SE |
| K902444 | Clearview(Tm) Angioscopic Irrigation PumpDQI · Traditional | 08/30/1990SE |
| K901010 | Flexible CholedochoscopeFBN · Traditional | 05/22/1990SE |
Questions and answers
When was Optical Valvulotome cleared by the FDA?
Optical Valvulotome (K914385) received a 510(k) decision of Substantially Equivalent on March 2, 1992, 153 days after the submission was received.
What is the product code of K914385?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.