CELSITE, MODELS ST401L, ST405L— 510(k) K994111
Substantially EquivalentB. Braun/Mcgaw
FDA 510(k) clearance K994111 for CELSITE, MODELS ST401L, ST405L, Substantially Equivalent on 2000-01-03. Applicant: B. Braun/Mcgaw. Device class: 2.
Clearance details
- Applicant
- B. Braun/Mcgaw
- 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
- Allentown, PA, US
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More clearances from B. Braun/Mcgaw
view allAdverse 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.