Rmi Normocluder Coronary Artery Occluder
FDA 510(k) K915869 · Research Medical, Inc.
510(k) numberK915869
Submission
- Device name
- Rmi Normocluder Coronary Artery Occluder
- Applicant
- Research Medical, Inc.
Midvale, UT, US - Received
- December 31, 1991
- Decision date
- December 8, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MJN – Catheter, Intravascular Occluding, Temporary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
Other 510(k)s with product code MJN
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|---|---|---|---|
| K243795 | pREBOA-PRO CatheterMJN · Traditional | Prytime Medical Devices, Inc. | 09/05/2025SE |
| K251358 | Bridge Plus Occlusion Balloon (590-002)MJN · Traditional | Philips Image Guided Therapy Devices | 06/24/2025SE |
| K221294 | preCARDIA Occlusion SystemMJN · Traditional | Abiomed, Inc. | 06/30/2023SESU |
| K214060 | LANDMARK REBOA CatheterMJN · Traditional | Zien Medical Technologies, Inc. | 09/19/2022SE |
| K211610 | Fogarty Occlusion CatheterMJN · Traditional | Edwards Lifesciences, LLC | 02/14/2022SE |
| K212324 | RenovoCathMJN · Special | Renovorx, Inc. | 08/23/2021SE |
| K210602 | AortaSTAT Occlusion DeviceMJN · Traditional | Renalpro Medical, Inc. | 07/09/2021SE |
| K210358 | Neurescue deviceMJN · Traditional | Neurescue Aps | 05/21/2021SE |
| K201652 | COBRA-OS KitMJN · Traditional | Front Line Medical Technologies, Inc. | 02/22/2021SESK |
| K203540 | Bridge Occlusion BalloonMJN · Special | Spectranetics, Inc. | 12/23/2020SE |
More from Spectranetics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970739 | Rmi Hemoconcentrator Preference PackKDI · Traditional | 07/08/1997SE |
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | 02/19/1997SE |
| K961927 | Rmi Hemoconcentractor Tubing SetDWF · Traditional | 08/13/1996SE |
| K960098 | Rmi Internal Mammary Artery CannulaDQR · Traditional | 03/26/1996SE |
| K951344 | Rmi HemoconcentratorKDI · Traditional | 08/15/1995SE |
| K922083 | Rmi Surgiccal Site Visualization WandFQH · Traditional | 01/29/1993SE |
| K920936 | Rmi External Coronary Artery OccluderDXC · Traditional | 12/18/1992SE |
| K920676 | Rmi SofclampDSS · Traditional | 04/15/1992SE |
| K910221 | Rmi Vascular Tourniquet KitDXC · Traditional | 05/16/1991SE |
| K901231 | Rmi Cardioplegia Delivery KitsDWF · Traditional | 06/08/1990SE |
Questions and answers
When was Rmi Normocluder Coronary Artery Occluder cleared by the FDA?
Rmi Normocluder Coronary Artery Occluder (K915869) received a 510(k) decision of Substantially Equivalent on December 8, 1992, 343 days after the submission was received.
What is the product code of K915869?
The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.