BD CAREFLOW CENTRAL VENOUS CATHETER
FDA 510(k) clearance K033500 · decided 2004-01-29
Clearance details
- K-number
- K033500
- Device name
- BD CAREFLOW CENTRAL VENOUS CATHETER
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2003-11-05
- Decision date
- 2004-01-29
- Days to decision
- 85 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Becton
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Careflow 14Ga x 20cm 2-lumen Central Venous Catheter Tray recall (Z-0629-05) | Becton Dickinson Infusion Therapy | 2005-03-18 |
| Careflow 7Fr x 20cm 3-lumen Central Venous Catheter Tray recall (Z-0630-05) | Becton Dickinson Infusion Therapy | 2005-03-18 |