MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM— 510(k) K933975
Substantially EquivalentMeadox Medicals, Div. Boston Scientific Corp.
FDA 510(k) clearance K933975 for MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM, Substantially Equivalent on 1993-10-06. Applicant: Meadox Medicals, Div. Boston Scientific Corp..
Clearance details
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
- Product code
- Code LIT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakland, NJ, US
Adverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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.