510(k) K130730
K130730 is an FDA 510(k) premarket notification submitted by Argon Medical for the device "V-STICK VASCULAR ACCESS SET". The FDA issued a decision of Substantially Equivalent on November 22, 2013. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Argon Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2013
- Date Received
- March 18, 2013
- 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