510(k) K172487
K172487 is an FDA 510(k) premarket notification submitted by Galt Medical Corp. for the device "Coaxial Dilator Set (Micro-Introducer)". The FDA issued a decision of Substantially Equivalent (kit) on October 16, 2017. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Galt Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- October 16, 2017
- Date Received
- August 17, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type