Origin Cardiac Stablizer Occluder
FDA 510(k) K970611 · Origin Medsystems, Inc.
510(k) numberK970611
Submission
- Device name
- Origin Cardiac Stablizer Occluder
- Applicant
- Origin Medsystems, Inc.
Menlo Park, CA, US - Received
- February 18, 1997
- Decision date
- August 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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| K972685 | Origin Ligator DeviceGCJ · Traditional | 10/01/1997SE |
| K965121 | CannulaHET · Traditional | 03/20/1997SE |
| K964171 | Vasoview Balloon Dissection SystemGCJ · Traditional | 02/14/1997SE |
| K962104 | Airlift Balloon Retracton SystemGCJ · Traditional | 09/11/1996SE |
| K962005 | Extrahand Balloon RetractorGCJ · Traditional | 08/12/1996SE |
| K960936 | Resposable Trocar System [5MM, 5MM Short, 10MM and 12MM Sizes]HET · Traditional | 07/24/1996SE |
| K960637 | 5MM EndoscopeGCJ · Traditional | 06/14/1996SE |
| K955163 | Dissection ProbeGEI · Traditional | 01/24/1996SE |
Questions and answers
When was Origin Cardiac Stablizer Occluder cleared by the FDA?
Origin Cardiac Stablizer Occluder (K970611) received a 510(k) decision of Substantially Equivalent on August 19, 1997, 182 days after the submission was received.
What is the product code of K970611?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.