510(k) K153494
K153494 is an FDA 510(k) premarket notification submitted by Alseal for the device "HQS Introducer (Model 2064-HQS)". The FDA issued a decision of Substantially Equivalent on Aug 25, 2016. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Alseal has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 25, 2016
- Date Received
- Dec 4, 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)