ASPIRA PLEURAL DRAINAGE SYSTEM— 510(k) K071095
Substantially EquivalentBard Access Systems, Inc.
FDA 510(k) clearance K071095 for ASPIRA PLEURAL DRAINAGE SYSTEM, Substantially Equivalent on 2007-05-18. Applicant: Bard Access Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bard Access Systems, Inc.
- Product code
- Code DWM
- Device class
- Class 2
- Regulation
- 21 CFR 870.5050
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code DWM
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- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
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Adverse events under product code DWM
product code DWM- Death
- 8
- Total
- 8
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.