510(k) K123544
K123544 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on February 12, 2013. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), 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
- February 12, 2013
- Date Received
- November 19, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type