510(k) K131446

INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES by Integra LifeSciences Corporation — Product Code DQR

K131446 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES". The FDA issued a decision of Substantially Equivalent on October 28, 2013. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2013
Date Received
May 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Catheter
Device Class
Class II
Regulation Number
870.1300
Review Panel
CV
Submission Type