PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter— 510(k) K151985
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K151985 for PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter, Substantially Equivalent on 2016-06-14. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake Ciy,, UT, US
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Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.