Clirpath Excimer Laser Catheter
FDA 510(k) K040067 · Spectranetics Corp.
510(k) numberK040067
Submission
- Device name
- Clirpath Excimer Laser Catheter
- Applicant
- Spectranetics Corp.
Colorado Springs, CO, US - Received
- January 14, 2004
- Decision date
- April 27, 2004
- 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 Clirpath Excimer Laser Catheter cleared by the FDA?
Clirpath Excimer Laser Catheter (K040067) received a 510(k) decision of Substantially Equivalent on April 27, 2004, 104 days after the submission was received.
What is the product code of K040067?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.