510(k) K082579
K082579 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "EVERCROSS .035 OTW PTA DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on November 20, 2008. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Ev3, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2008
- Date Received
- September 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type