Truepath Cto Device
FDA 510(k) K140288 · Boston Scientific Corp
510(k) numberK140288
Submission
- Device name
- Truepath Cto Device
- Applicant
- Boston Scientific Corp
Maple Grove, MN, US - Received
- February 5, 2014
- Decision date
- April 16, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Truepath Cto Device cleared by the FDA?
Truepath Cto Device (K140288) received a 510(k) decision of Substantially Equivalent on April 16, 2014, 70 days after the submission was received.
What is the product code of K140288?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.