510(k) K172591

Fixed Patient Leads ECG Cable (Model 3153) by Boston Scientific Corporation — Product Code DSA

K172591 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Fixed Patient Leads ECG Cable (Model 3153)". The FDA issued a decision of Substantially Equivalent on Nov 3, 2017. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Boston Scientific Corporation has 238 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 3, 2017
Date Received
Aug 29, 2017
Clearance Type
Special
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
510(k)