CVIS INSIGHT IMAGING CATHETER— 510(k) K897153
Substantially EquivalentCardiovascular Imaging Systems, Inc.
FDA 510(k) clearance K897153 for CVIS INSIGHT IMAGING CATHETER, Substantially Equivalent on 1990-03-26. Applicant: Cardiovascular Imaging Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Imaging Systems, Inc.
- Product code
- Code LYK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code LYK
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