MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM— 510(k) K950276
Substantially EquivalentEndosonics Corp.
FDA 510(k) clearance K950276 for MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 1995-09-22. Applicant: Endosonics Corp.. Device class: 2.
Clearance details
- Applicant
- Endosonics Corp.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Cordova, CA, US
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Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.