VENOUS DRAINAGE CANNULA WITH DURAFLO COATING

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

EDWARDS LIFESCIENCES, LLC.

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Venous Drainage Cannula With Duraflo Coating.

Pre-market Notification Details

• Device ID: K120072
• 510k Number: K120072
• Device Name: VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020
• Contact: Karen Jones
• Correspondent: Karen Jones; EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2012-01-10
• Decision Date: 2012-05-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00690103034127	K120072	000
00690103041033	K120072	000
00690103041057	K120072	000
00690103041088	K120072	000
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00690103185935	K120072	000