ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS— 510(k) K093965
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K093965 for ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS, Substantially Equivalent on 2010-03-17. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- 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
- Tempe, AZ, US
Recent devices under product code LIT
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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.