# K033500: BD Careflow Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jan 29, 2004 after 85 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Hydrocath Central Venous Catheter: named in the summary without a submission number

## Recalls of this device
- Jan 10, 2005 · Not classified · Z-0629-05: Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
- Jan 10, 2005 · Not classified · Z-0630-05: Various procedure trays and kits may have an insufficient seal, thus compromising sterility.

## Indications for use
The BD CareflowTM Central Venous Catheter is an intravascular catheter that is introduced into a patient's vascular system for short-term use (less than 30 days) using an introducer and guidewire. The catheter is used to sample blood, monitor blood pressure, or administer fluids.

Source page: https://510kreport.com/device/K033500
Methodology: https://510kreport.com/methodology