BD Cathena Safety IV Catheter
FDA 510(k) clearance K220584 · decided 2022-03-31
Clearance details
- K-number
- K220584
- Device name
- BD Cathena Safety IV Catheter
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-01
- Decision date
- 2022-03-31
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sandy, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Ca recall (Z-1808-2025) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-05-21 |
| REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1 recall (Z-0025-2024) | Becton Dickinson Infusion Therapy Systems Inc. | 2023-10-03 |