510(k) K152740
K152740 is an FDA 510(k) premarket notification submitted by Ashitaka Factory Of Terumo Corp. for the device "Radifocus Glidewire". The FDA issued a decision of Substantially Equivalent on Nov 16, 2015. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Ashitaka Factory Of Terumo Corp. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 2015
- Date Received
- Sep 23, 2015
- Clearance Type
- Traditional
- 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)