PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set— 510(k) K153440
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K153440 for PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set, Substantially Equivalent on 2016-08-18. Applicant: C.R. Bard, Inc..
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code FPA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake Ciy,, UT, US
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.