510(k) K152913
K152913 is an FDA 510(k) premarket notification submitted by Creganna Medical Aslo Business AS Cregganna Tactx Medical for the device "GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle". The FDA issued a decision of Substantially Equivalent on Jul 21, 2016. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Creganna Medical Aslo Business AS Cregganna Tactx Medical has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 21, 2016
- Date Received
- Oct 2, 2015
- Clearance Type
- Traditional
- 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
- 510(k)