510(k) K163444
K163444 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "Spectre guidewire". The FDA issued a decision of Substantially Equivalent on Jan 6, 2017. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Vascular Solutions, Inc. has 114 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 6, 2017
- Date Received
- Dec 8, 2016
- 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)