510(k) K051670
K051670 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "RF TUNNELER WIRE". The FDA issued a decision of Substantially Equivalent on March 30, 2006. The device falls under product code PDU (Catheter For Crossing Total Occlusions), a Class II device regulated under 21 CFR 870.1250. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2006
- Date Received
- June 22, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter For Crossing Total Occlusions
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.