CTS Midcab Coronary Shunt
FDA 510(k) K963503 · Cardiothoracic Systems, Inc.
510(k) numberK963503
Submission
- Device name
- CTS Midcab Coronary Shunt
- Applicant
- Cardiothoracic Systems, Inc.
Cupertino, CA, US - Received
- September 3, 1996
- Decision date
- April 3, 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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| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | Edwards Lifesciences | 06/05/2026SE |
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| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
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| K232577 | Radial Compression DeviceDXC · Traditional | Ningbo Dizegens Medical Science Co.,Ltd | 01/18/2024SE |
| K230281 | PicoclampDXC · Traditional | Kono Seisakusho Co., Ltd. | 10/23/2023SE |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
| K230248 | ViolaDXC · Special | Vascular Graft Solutions, Ltd. | 02/28/2023SE |
More from Vascular Graft Solutions, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K010117 | Guidant Axius Coronary ShuntDXC · Traditional | 04/04/2001SE |
| K983270 | Voyager Quad CannulaDWF · Traditional | 07/28/1999SE |
| K982419 | Heart-Lift Balloon PositionerMWS · Traditional | 01/13/1999SE |
| K983135 | Blower/MisterFQH · Traditional | 11/13/1998SE |
| K963965 | CTS Midcab StitcherGEI · Traditional | 03/17/1998SE |
| K970638 | CTS Midcab Fixedn Diameter Coronary ShuntDXC · Traditional | 10/30/1997SE |
| K963930 | CTS Midcab/Svh Bipolar ScissorsGEI · Traditional | 01/16/1997SE |
Questions and answers
When was CTS Midcab Coronary Shunt cleared by the FDA?
CTS Midcab Coronary Shunt (K963503) received a 510(k) decision of Substantially Equivalent on April 3, 1997, 212 days after the submission was received.
What is the product code of K963503?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.