LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING— 510(k) K053589
Substantially EquivalentBard Access Systems, Inc.
FDA 510(k) clearance K053589 for LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING, Substantially Equivalent on 2006-04-13. Applicant: Bard Access Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bard Access Systems, Inc.
- Product code
- Code MSD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code MSD
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- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
- K240146 — BD Prevue II Peripheral Vascular Access System
Adverse events under product code MSD
product code MSD- Death
- 67
- Injury
- 545
- Malfunction
- 3,661
- Total
- 4,273
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.