ENDOSONICS TRAK BACK DEVICE— 510(k) K990271
Substantially EquivalentEndosonics Corp.
FDA 510(k) clearance K990271 for ENDOSONICS TRAK BACK DEVICE, Substantially Equivalent on 1999-08-30. Applicant: Endosonics Corp.. Device class: 2.
Clearance details
- Applicant
- Endosonics Corp.
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Cordova,, CA, US
Recent devices under product code DQX
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- K982329 — VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
- K965223 — RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
- K963290 — COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
- K962293 — ENDOSONICS AUTOMATIC PULL BACK DEVICE
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.