510(k) K123707
K123707 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE". The FDA issued a decision of Substantially Equivalent on February 28, 2013. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Cook, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2013
- Date Received
- December 3, 2012
- 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