510(k) K113849
K113849 is an FDA 510(k) premarket notification submitted by Alseal for the device "HQS INTRODUCER". The FDA issued a decision of Substantially Equivalent on Jul 31, 2012. 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
- Jul 31, 2012
- Date Received
- Dec 29, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
- 510(k)