510(k) K163575
K163575 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Inqwire Diagnostic Guide Wire". The FDA issued a decision of Substantially Equivalent on Mar 3, 2017. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 2017
- Date Received
- Dec 19, 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)