510(k) K203556

Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables by Medtronic, Inc. — Product Code DSA

K203556 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables". The FDA issued a decision of Substantially Equivalent on July 12, 2021. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Medtronic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2021
Date Received
December 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type