LIFE-LINE(TM) VASCULAR ACCESS SYSTEM— 510(k) K895030
UnknownMedical Engineering and Development Institute
FDA 510(k) clearance K895030 for LIFE-LINE(TM) VASCULAR ACCESS SYSTEM, Unknown on 1990-04-17. Applicant: Medical Engineering and Development Institute. Device class: 2.
Clearance details
- Applicant
- Medical Engineering and Development Institute
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- West Lafayette, IN, US
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More clearances from Medical Engineering and Development Institute
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.