# K071361: R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005

- Pathway: 510(k) (Traditional)
- Applicant: R4 Vascular, Inc.
- Decided: Aug 20, 2007 after 97 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
Longest line of descent: 7 generations back to K001901 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053345: Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D, Medcomp (2006) Summary page 1.

## Indications for use
THE R4 VASCULAR INC. PEGASUS CT PICC IS INDICATED FOR SHORT TERM AND LONG-TERM PERIPHERAL ACCESS TO THE CENTRAL VENOUS SYSTEM FOR INTRAVENOUS THERAPY AND POWER INJECTION OF CONTRAST MEDIA. FOR BLOOD SAMPLING, INFUSION, OR THERAPIES, USE A 4F OR LARGER CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 5F AND 6F PEGASUS CT PICC CATHETER MAY NOT EXCEED 300PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 5CC/SEC FOR 5F AND 6F CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 4F PEGASUS CT PICC CATHETER MAY NOT EXCEED 200PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 4CC/SEC FOR A 4F CATHETER.

Source page: https://510kreport.com/device/K071361
Methodology: https://510kreport.com/methodology