510(k) K142235
K142235 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. St Jude Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2014
- Date Received
- August 13, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type