510(k) K191608
K191608 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Impress Angiographic Catheter". The FDA issued a decision of Substantially Equivalent on Jul 16, 2019. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 16, 2019
- Date Received
- Jun 17, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
- 510(k)