510(k) K172591
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)