Reverse Medical Micro Vascular Plug (MVP) System
FDA 510(k) K133282 · Reverse Medical Corporation
510(k) numberK133282
Submission
- Device name
- Reverse Medical Micro Vascular Plug (MVP) System
- Applicant
- Reverse Medical Corporation
Irvine, CA, US - Received
- October 25, 2013
- Decision date
- November 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
More from Nuvascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150108 | Reverse Medical Micro Vascular Plug SystemKRD · Special | 04/22/2015SE |
| K141313 | Reverse Medical Micro Vascular Plug SystemKRD · Special | 06/18/2014SE |
| K130858 | Reverse Medical MicrocatheterDQY · Traditional | 10/11/2013SE |
| K123803 | Reverse Medical Micro Vascular Plug (MVP) SystemKRD · Traditional | 07/02/2013SE |
| K122684 | Reverse Medical MicrocatheterDQY · Traditional | 12/07/2012SE |
| K112262 | Reflex Ballon Guide CatheterDQY · Traditional | 11/02/2011SE |
| K102418 | Reverse Medical Report Guide Catheter SystemDQY · Traditional | 04/15/2011SE |
| K110055 | Reverse Medical Reflex Guide CatheterDQY · Traditional | 04/05/2011SE |
| K091563 | Recruit MicrocatheterMMX · Traditional | 07/30/2009SE |
Questions and answers
When was Reverse Medical Micro Vascular Plug (MVP) System cleared by the FDA?
Reverse Medical Micro Vascular Plug (MVP) System (K133282) received a 510(k) decision of Substantially Equivalent on November 27, 2013, 33 days after the submission was received.
What is the product code of K133282?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.