510(k) K152080
K152080 is an FDA 510(k) premarket notification submitted by KANEKA Corporation for the device "Metacross OTW PTA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on Sep 24, 2015. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. KANEKA Corporation has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 24, 2015
- Date Received
- Jul 27, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)