Rmi Internal Mammary Artery Cannula
FDA 510(k) K960098 · Research Medical, Inc.
510(k) numberK960098
Submission
- Device name
- Rmi Internal Mammary Artery Cannula
- Applicant
- Research Medical, Inc.
Midvale, UT, US - Received
- January 11, 1996
- Decision date
- March 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQR – Cannula, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1300
- Specialty
- Cardiovascular
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| K902674 | Datascope Arterial Cannula W/Access PortDQR · Traditional | Datascope Corp. | 01/16/1991SE |
| K894784 | Modified Shiley Femoral Venous CannulaDQR · Traditional | Shiley, Inc. | 03/28/1990SE |
| K894243 | Rmi Arterial Perfusion CannulaDQR · Traditional | Research Medical, Inc. | 09/19/1989SE |
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| K884375 | Translumbar Aortography Needle CatheterDQR · Traditional | Argon Medical Corp. | 01/11/1989SE |
More from Argon Medical Corp.
| 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 |
| 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 |
| K915869 | Rmi Normocluder Coronary Artery OccluderMJN · Traditional | 12/08/1992SE |
| 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 Internal Mammary Artery Cannula cleared by the FDA?
Rmi Internal Mammary Artery Cannula (K960098) received a 510(k) decision of Substantially Equivalent on March 26, 1996, 75 days after the submission was received.
What is the product code of K960098?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.