510(k) K072278
K072278 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "BRK TRANSSEPTAL NEEDLE". The FDA issued a decision of Substantially Equivalent on September 13, 2007. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. St Jude Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2007
- Date Received
- August 16, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Trocar
- Device Class
- Class II
- Regulation Number
- 870.1390
- Review Panel
- CV
- Submission Type