NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER— 510(k) K953608
Substantially EquivalentMeadox Medicals, Div. Boston Scientific Corp.
FDA 510(k) clearance K953608 for NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER, Substantially Equivalent on 1995-12-20. 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.