510(k) K062261
K062261 is an FDA 510(k) premarket notification submitted by Inspired Ideas, Incorporated for the device "FOAM RING PORT PROTECTOR". The FDA issued a decision of Substantially Equivalent on April 9, 2007. The device falls under product code OBK (Port, Protector/Cushion), a Class II device regulated under 21 CFR 880.5965.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2007
- Date Received
- August 4, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Port, Protector/Cushion
- Device Class
- Class II
- Regulation Number
- 880.5965
- Review Panel
- HO
- Submission Type
Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.