510(k) K120086
K120086 is an FDA 510(k) premarket notification submitted by Cardiosolutions for the device "CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM". The FDA issued a decision of Substantially Equivalent on April 24, 2012. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Cardiosolutions has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2012
- Date Received
- January 11, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Steerable
- Device Class
- Class II
- Regulation Number
- 870.1280
- Review Panel
- CV
- Submission Type