510(k) K201595
K201595 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Merit Hydrophilic Guide Wire". The FDA issued a decision of Substantially Equivalent on Oct 14, 2020. 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
- Oct 14, 2020
- Date Received
- Jun 12, 2020
- 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)