MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519— 510(k) K093406
Substantially EquivalentAngioDynamics, Inc.
FDA 510(k) clearance K093406 for MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519, Substantially Equivalent on 2010-03-25. Applicant: AngioDynamics, Inc.. Device class: 2.
Clearance details
- Applicant
- AngioDynamics, Inc.
- Product code
- Product code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Queensburgy, NY, US
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More clearances from AngioDynamics, Inc.
view allAdverse 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.