510(k) K110407
K110407 is an FDA 510(k) premarket notification submitted by Stealth Therapeutics, Incorporated for the device "INVISIPORT". The FDA issued a decision of Substantially Equivalent on October 13, 2011. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Stealth Therapeutics, Incorporated has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2011
- Date Received
- February 14, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5965
- Review Panel
- HO
- Submission Type