MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES

Cable, Transducer And Electrode, Patient, (including Connector)

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 5471 & 5471l Sterile Disposable Patient Cable Assemblies.

Pre-market Notification Details

• Device ID: K960446
• 510k Number: K960446
• Device Name: MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
• Classification: Cable, Transducer And Electrode, Patient, (including Connector)
• Applicant: MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576
• Contact: Valerie K Stuhr
• Correspondent: Valerie K Stuhr; MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576
• Product Code: DSA
• CFR Regulation Number: 870.2900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-02-01
• Decision Date: 1996-05-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20643169307357	K960446	000
20643169307333	K960446	000
20763000181165	K960446	000