510(k) K051373
K051373 is an FDA 510(k) premarket notification submitted by Stereotaxis, Inc. for the device "CRONUS GUIDEWIRE, MODEL 001-001470-1". The FDA issued a decision of Substantially Equivalent on December 9, 2005. The device falls under product code NDQ (System, Catheter Or Guidewire, Steerable (Magnetic)), a Class II device regulated under 21 CFR 870.1290. Stereotaxis, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2005
- Date Received
- May 26, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Catheter Or Guidewire, Steerable (Magnetic)
- Device Class
- Class II
- Regulation Number
- 870.1290
- Review Panel
- NE
- Submission Type