510(k) K161873
K161873 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "Pacel Flow Directed Pacing Catheter". The FDA issued a decision of Substantially Equivalent on November 22, 2016. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. St Jude Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2016
- Date Received
- July 7, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type