Guidant Syncrus Internal Cardioversion System
FDA 510(k) K024071 · Guidant Corporation, Cardiac Surgery
510(k) numberK024071
Submission
- Device name
- Guidant Syncrus Internal Cardioversion System
- Applicant
- Guidant Corporation, Cardiac Surgery
Santa Clara, CA, US - Received
- December 10, 2002
- Decision date
- February 14, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHW – Electrode, Pacing And Cardioversion, Temporary, Epicardial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3680
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.
Other 510(k)s with product code NHW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020701 | Syncrus Internal Cardioversion SystemNHW · Traditional | Guidant Corporation, Cardiac Surgery | 05/24/2002SE |
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| K041340 | Guidant Microwave Ablation SystemNEY · Traditional | 07/28/2004SE |
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| K023629 | Essex Dissection Cannula, Model SXD-1100, Essex Dissection Tip, Model SXD-1200GCJ · Traditional | 11/12/2002SE |
| K022718 | Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002GEI · Traditional | 08/28/2002SE |
| K020701 | Syncrus Internal Cardioversion SystemNHW · Traditional | 05/24/2002SE |
| K020143 | Vasoview 5 Harvesting CannulaHET · Traditional | 02/20/2002SE |
Questions and answers
When was Guidant Syncrus Internal Cardioversion System cleared by the FDA?
Guidant Syncrus Internal Cardioversion System (K024071) received a 510(k) decision of Substantially Equivalent on February 14, 2003, 66 days after the submission was received.
What is the product code of K024071?
The FDA product code is NHW – Electrode, Pacing And Cardioversion, Temporary, Epicardial, a Class II (moderate risk) device regulated under 21 CFR 870.3680.