CATHSCANNER(R) PTA BALLOON DILATATION CATHETER— 510(k) K902454
Substantially EquivalentEndosonics Corp.
FDA 510(k) clearance K902454 for CATHSCANNER(R) PTA BALLOON DILATATION CATHETER, Substantially Equivalent on 1990-08-30. Applicant: Endosonics Corp.. Device class: 2.
Clearance details
- Applicant
- Endosonics Corp.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Cordova, CA, US
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- 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 LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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.