# K131446: Integra Jarit Heparin Cannulas, Injectors, and Needles

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Oct 28, 2013 after 161 days
- Product code: DQR (Cannula, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030788 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030788: Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators, Geister Medizin Technik GmbH (2003) Summary page 2.
- (no number) DeBakey Heparin Cannula: named in the summary without a submission number
- (no number) Stoney Heparin Injector: named in the summary without a submission number
- (no number) Heparin Flushing Needle: named in the summary without a submission number

## Indications for use
Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.

Source page: https://510kreport.com/device/K131446
Methodology: https://510kreport.com/methodology