INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES

Cannula, Catheter

INTEGRA LIFESCIENCES CORPORATION

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Jarit Heparin Cannulas, Injectors, And Needles.

Pre-market Notification Details

• Device ID: K131446
• 510k Number: K131446
• Device Name: INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
• Classification: Cannula, Catheter
• Applicant: INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402
• Contact: Stephanie N Sheesley
• Correspondent: Stephanie N Sheesley; INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402
• Product Code: DQR
• CFR Regulation Number: 870.1300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-05-20
• Decision Date: 2013-10-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M2743103841	K131446	000
M2743103821	K131446	000
M2743103801	K131446	000
M2743103791	K131446	000
M2743103831	K131446	000