510(k) K190106
Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle by
Centerline Biomedical, Inc.
— Product Code DQK
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2019
- Date Received
- January 22, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type