510(k) K162316
K162316 is an FDA 510(k) premarket notification submitted by Arravasc, Ltd. for the device "Pirouette 014". The FDA issued a decision of Substantially Equivalent on Nov 22, 2016. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Arravasc, Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 22, 2016
- Date Received
- Aug 18, 2016
- Clearance Type
- Special
- 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)