Cvis Insight III System
FDA 510(k) K921750 · Cardiovascular Imaging Systems, Inc.
510(k) numberK921750
Submission
- Device name
- Cvis Insight III System
- Applicant
- Cardiovascular Imaging Systems, Inc.
Sunnyvale, CA, US - Received
- April 13, 1992
- Decision date
- July 13, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ(37410/456221 & BSC, Sonicath Ultra…ITX · Traditional | 06/20/1997SE |
| K942231 | Microview Ii/Microrail II CathetersDQO · Traditional | 08/01/1994SE |
| K933517 | Automatic Pull Back DeviceDQX · Traditional | 10/15/1993SE |
| K930232 | Cvis Insight Imaging Guide CatheterDQO · Traditional | 07/21/1993SE |
| K924922 | Cvis Insight Imaging CatheterDQO · Traditional | 06/29/1993SE |
| K930311 | Cvis LongviewDQO · Traditional | 06/02/1993SE |
| K921879 | Cbis Catheter Pull-Back DeviceDQO · Traditional | 07/16/1992SE |
| K921631 | Cvis Insight Imaging Catheter for IntraluminalITX · Traditional | 07/02/1992SE |
| K921148 | Cvis Insight Catheters for Intracardiac UseITX · Traditional | 06/16/1992SE |
| K921147 | Cvis Insight Imaging Catheter for Intraluminal UseITX · Traditional | 06/16/1992SE |
Questions and answers
When was Cvis Insight III System cleared by the FDA?
Cvis Insight III System (K921750) received a 510(k) decision of Substantially Equivalent on July 13, 1992, 91 days after the submission was received.
What is the product code of K921750?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.