MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652— 510(k) K961336
Substantially EquivalentMedtronic PS Medical
FDA 510(k) clearance K961336 for MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652, Substantially Equivalent on 1996-07-18. Applicant: Medtronic PS Medical.
Clearance details
- Applicant
- Medtronic PS Medical
- Product code
- Code LJS
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.