# K083763: Zeus CT Picc 4 FR and 5 FR Single and Dual Lumen

- Pathway: 510(k) (Traditional)
- Applicant: R4 Vascular, Inc.
- Decided: Mar 16, 2009 after 88 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.
37 later devices descend from it; 3 cite it directly.
8 of 38 devices 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) V-Cath (Polyurethane) Power PICC (Power-V): named in the summary without a submission number
- (no number) Tyco Palindrome Emerald: named in the summary without a submission number

## Most influential descendants
- K121089: Nmi Picc Iii (2012), 23 descendants of its own
- K122882: Nmi Hpicc Iii (2012), 12 descendants of its own
- K112896: Arrw Evolution (2012), 12 descendants of its own
- K131942: Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter (2013), 7 descendants of its own
- K133264: Nmi Picc Iii (2013), 6 descendants of its own

## Indications for use
The Zeus™ CT PICC is indicated for short or long-term (less than or greater than 30 days) peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The maximum recommednded infusion rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.

Source page: https://510kreport.com/device/K083763
Methodology: https://510kreport.com/methodology