ORIGEN REINFORCED DUAL LUMEN CATHETER
FDA 510(k) clearance K113869 · decided 2012-07-26
Clearance details
- K-number
- K113869
- Device name
- ORIGEN REINFORCED DUAL LUMEN CATHETER
- Applicant
- Origen Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-30
- Decision date
- 2012-07-26
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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