510(k) K090728
K090728 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "HYPERGLIDE OCCLUSION BALLOON SYSTEM". The FDA issued a decision of Substantially Equivalent on April 16, 2009. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Ev3, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2009
- Date Received
- March 19, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular Occluding, Temporary
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type