EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE

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 Edward Proplege Peripheral Retrograde Cardioplegia Device.

Pre-market Notification Details

• Device ID: K120780
• 510k Number: K120780
• Device Name: EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: EDWARDS LIFESCIENCES, LLC. 12050 LONE PEAK PKWY. Draper, UT 84020
• Contact: Dannette Crooms
• Correspondent: Dannette Crooms; 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: 2012-03-14
• Decision Date: 2012-06-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00690103189995	K120780	000
00840479400013	K120780	000