VACCESS PTA BALLOON DILATATION CATHETER— 510(k) K073472
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K073472 for VACCESS PTA BALLOON DILATATION CATHETER, Substantially Equivalent on 2008-01-09. 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
- Special
- Location
- Tempe, AZ, US
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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 →
Recalls naming K073472
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073472.
Data sourced from openFDA. This site is unofficial and independent of the FDA.