510(k) K111644
K111644 is an FDA 510(k) premarket notification submitted by Great Batch Medical for the device "MOBICATH TRANSSEPTAL NEEDLE". The FDA issued a decision of Substantially Equivalent on October 3, 2011. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Great Batch Medical has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2011
- Date Received
- June 13, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trocar
- Device Class
- Class II
- Regulation Number
- 870.1390
- Review Panel
- CV
- Submission Type