RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM— 510(k) K965223
Substantially EquivalentEndosonics Corp.
FDA 510(k) clearance K965223 for RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM, Substantially Equivalent on 1998-06-29. 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
Recent devices under product code IYO
view allMore clearances from Endosonics Corp.
view all- K000820 — AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
- K990271 — ENDOSONICS TRAK BACK DEVICE
- K982329 — VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
- K963290 — COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
- K962293 — ENDOSONICS AUTOMATIC PULL BACK DEVICE
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.