VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238— 510(k) K031844
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K031844 for VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238, Substantially Equivalent on 2003-07-15. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Glens Falls, NY, US
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Adverse events under product code LJT
product code LJT- Death
- 234
- Injury
- 6,468
- Malfunction
- 5,326
- Other
- 2
- Total
- 12,030
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.