BUSSE EPIDURAL CATHETER— 510(k) K070465
Substantially EquivalentBusse Hospital Disposables, Inc.
FDA 510(k) clearance K070465 for BUSSE EPIDURAL CATHETER, Substantially Equivalent on 2007-07-19. Applicant: Busse Hospital Disposables, Inc..
Clearance details
- Applicant
- Busse Hospital Disposables, Inc.
- Product code
- Code BSO
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hauppauge, NY, US
Adverse events under product code BSO
product code BSO- Malfunction
- 688
- Total
- 688
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.