510(k) K110553
K110553 is an FDA 510(k) premarket notification submitted by Asahi Intecc USA, Inc. for the device "ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on Mar 18, 2011. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 18, 2011
- Date Received
- Feb 28, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type
- 510(k)