510(k) K140015
K140015 is an FDA 510(k) premarket notification submitted by Cardiosolutions, Inc. for the device "CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER". The FDA issued a decision of Substantially Equivalent on February 5, 2014. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Cardiosolutions, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2014
- Date Received
- January 2, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type