Rmi Sofclamp
FDA 510(k) K920676 · Research Medical, Inc.
510(k) numberK920676
Submission
- Device name
- Rmi Sofclamp
- Applicant
- Research Medical, Inc.
Midvale, UT, US - Received
- February 14, 1992
- Decision date
- April 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSS – Clip, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3250
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983744 | Mcas (Modular Clip Applier System)DSS · Traditional | Applied Medical Resources | 01/21/1999SE |
| K961333 | Heartport Multifire Clip ApplierDSS · Traditional | Heartport, Inc. | 11/15/1996SE |
| K920104 | Identi Loops Degania SiliconeDSS · Traditional | Puritas Health Care, Inc. | 04/20/1992SE |
| K914523 | Cri Vessel Occlusin System/Cri Occlusion CoilDSS · Traditional | Catheter Research C/O Burditt, Bowles & Radzius | 01/10/1992SE |
| K901303 | Horizon Surgical Ligating and Marking ClipDSS · Traditional | Horizon Surgical, Inc. | 06/05/1990SE |
| K883909 | Surgical Spring ClipsDSS · Traditional | Applied Vascular Devices, Inc. | 12/27/1988SE |
| K771021 | Auto-ClipDSS · Traditional | Axiom Medical, Inc. | 06/14/1977SE |
More from Axiom Medical, 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 |
| K915869 | Rmi Normocluder Coronary Artery OccluderMJN · Traditional | 12/08/1992SE |
| K910221 | Rmi Vascular Tourniquet KitDXC · Traditional | 05/16/1991SE |
| K901231 | Rmi Cardioplegia Delivery KitsDWF · Traditional | 06/08/1990SE |
Questions and answers
When was Rmi Sofclamp cleared by the FDA?
Rmi Sofclamp (K920676) received a 510(k) decision of Substantially Equivalent on April 15, 1992, 61 days after the submission was received.
What is the product code of K920676?
The FDA product code is DSS – Clip, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.3250.