Regulatory filing
Z-0489-2021 (us_fda)
Intuitive Ion Endoluminal System fully-articulating catheter (REF 490105): distal tip ring may become dislodged during the procedure. FDA Class II.
fda recall · recalled · decided 2020-12-02
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- Revision history: /regulatory-filings/fda-recall-intuitive-ion-catheter-2020/history
- Data documentation: /data
Key facts
- Jurisdiction
- us_fda
- Filing type
- fda recall
- Status
- recalled
- Filing number
- Z-0489-2021
- Filing date
- 2020-10-23
- Decision date
- 2020-12-02
- Verification posture
- verified
Applicant
Covered models (1)
Sources (1)
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Identity
2d33f35b-e224-4554-a1c1-ae83f81eb292