IV ADMINISTRATION AND CONNECT SETS
FDA 510(k) clearance K033301 · decided 2004-03-04
Clearance details
- K-number
- K033301
- Device name
- IV ADMINISTRATION AND CONNECT SETS
- Applicant
- Codan US Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-14
- Decision date
- 2004-03-04
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually recall (Z-2433-2020) | Codan US Corporation | 2020-06-26 |