PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.— 510(k) K890492
Substantially EquivalentEndosonics Corp.
FDA 510(k) clearance K890492 for PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH., Substantially Equivalent on 1989-03-02. Applicant: Endosonics Corp.. Device class: 2.
Clearance details
- Applicant
- Endosonics Corp.
- Product code
- Code DXO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2870
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Cordova, CA, US
Recent devices under product code DXO
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- K990271 — ENDOSONICS TRAK BACK DEVICE
- 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
Adverse events under product code DXO
product code DXO- Death
- 10
- Injury
- 156
- Malfunction
- 884
- Total
- 1,050
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.