# K082481: Flowpicc Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vasonova, Inc.
- Decided: Dec 17, 2008 after 111 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- 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) Bard PowerPICC Catheter: named in the summary without a submission number
- (no number) Cook Turbo-Ject Catheter: named in the summary without a submission number

## Indications for use
The FlowPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a SF or larger catheter. The maximum recommended infusion rate is 5cc/sec. The FlowPICC Catheter is indicated for use by itself or with the FlowPICC System (Stylet and Console) sold separately.

Source page: https://510kreport.com/device/K082481
Methodology: https://510kreport.com/methodology