ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for One Piece Pediatric Arterial Cannula, Model: 77006, 77106.

Pre-market Notification Details

• Device ID: K024069
• 510k Number: K024069
• Device Name: ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428
• Contact: Ronald W Bennett
• Correspondent: Ronald W Bennett; MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-12-10
• Decision Date: 2003-01-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000946692	K024069	000
20613994879886	K024069	000
20613994879893	K024069	000
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20613994880004	K024069	000
20613994880011	K024069	000
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20763000091013	K024069	000
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