Pioneer Plus Catheter, Model Plus 120
FDA 510(k) K101777 · Medtronic Vascular
510(k) numberK101777
Submission
- Device name
- Pioneer Plus Catheter, Model Plus 120
- Applicant
- Medtronic Vascular
Santa Rosa, CA, US - Received
- June 25, 2010
- Decision date
- July 23, 2010
- 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 Pioneer Plus Catheter, Model Plus 120 cleared by the FDA?
Pioneer Plus Catheter, Model Plus 120 (K101777) received a 510(k) decision of Substantially Equivalent on July 23, 2010, 28 days after the submission was received.
What is the product code of K101777?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.