Microview Ii/Microrail II Catheters
FDA 510(k) K942231 · Cardiovascular Imaging Systems, Inc.
510(k) numberK942231
Submission
- Device name
- Microview Ii/Microrail II Catheters
- Applicant
- Cardiovascular Imaging Systems, Inc.
Sunnyvale, CA, US - Received
- May 6, 1994
- Decision date
- August 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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More from Cordis US Corp
| 510(k) | Device | Decision |
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| K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ(37410/456221 & BSC, Sonicath Ultra…ITX · Traditional | 06/20/1997SE |
| 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 |
| K921750 | Cvis Insight III SystemITX · Traditional | 07/13/1992SE |
| 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 Microview Ii/Microrail II Catheters cleared by the FDA?
Microview Ii/Microrail II Catheters (K942231) received a 510(k) decision of Substantially Equivalent on August 1, 1994, 87 days after the submission was received.
What is the product code of K942231?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.