CVIS INSIGHT IMAGING CATHETER— 510(k) K901562
Substantially EquivalentCardiovascular Imaging Systems, Inc.
FDA 510(k) clearance K901562 for CVIS INSIGHT IMAGING CATHETER, Substantially Equivalent on 1990-07-09. Applicant: Cardiovascular Imaging Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Imaging Systems, Inc.
- Product code
- Code DXK
- Device class
- Class 2
- Regulation
- 21 CFR 870.2330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code DXK
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