Pioneer Catheter
FDA 510(k) K072155 · Medtronic, Inc.
510(k) numberK072155
Submission
- Device name
- Pioneer Catheter
- Applicant
- Medtronic, Inc.
Santa Rosa, CA, US - Received
- August 3, 2007
- Decision date
- October 5, 2007
- 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 Pioneer Catheter cleared by the FDA?
Pioneer Catheter (K072155) received a 510(k) decision of Substantially Equivalent on October 5, 2007, 63 days after the submission was received.
What is the product code of K072155?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.