RF Tunneler Wire
FDA 510(k) K051670 · Baylis Medical Co., Inc.
510(k) numberK051670
Submission
- Device name
- RF Tunneler Wire
- Applicant
- Baylis Medical Co., Inc.
Mississauga, Ontario, CA - Received
- June 22, 2005
- Decision date
- March 30, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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.
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Questions and answers
When was RF Tunneler Wire cleared by the FDA?
RF Tunneler Wire (K051670) received a 510(k) decision of Substantially Equivalent on March 30, 2006, 281 days after the submission was received.
What is the product code of K051670?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.