Offroad Re-Entry Catheter System
FDA 510(k) K131914 · Boston Scientific Corp
510(k) numberK131914
Submission
- Device name
- Offroad Re-Entry Catheter System
- Applicant
- Boston Scientific Corp
Maple Grove, MN, US - Received
- June 26, 2013
- Decision date
- October 31, 2013
- 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 Offroad Re-Entry Catheter System cleared by the FDA?
Offroad Re-Entry Catheter System (K131914) received a 510(k) decision of Substantially Equivalent on October 31, 2013, 127 days after the submission was received.
What is the product code of K131914?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.