Clirpath Turbo Excimer Laser Catheters
FDA 510(k) K052296 · Spectranetics Corp.
510(k) numberK052296
Submission
- Device name
- Clirpath Turbo Excimer Laser Catheters
- Applicant
- Spectranetics Corp.
Colorado Springs, CO, US - Received
- August 23, 2005
- Decision date
- September 2, 2005
- 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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| K251158 | PowerWire® 14 Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 09/11/2025SESK |
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| K230159 | SoundBite® Crossing System XS PeripheralPDU · Traditional | Soundbite Medical Solutions, Inc. | 08/28/2023SE |
| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | Avinger, Inc. | 04/25/2023SE |
| K221163 | Tunnel Crossing CatheterPDU · Traditional | Tractus Vascular, LLC | 01/19/2023SE |
| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)PDU · Traditional | Ra Medical Systems,Inc | 06/29/2022SE |
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Questions and answers
When was Clirpath Turbo Excimer Laser Catheters cleared by the FDA?
Clirpath Turbo Excimer Laser Catheters (K052296) received a 510(k) decision of Substantially Equivalent on September 2, 2005, 10 days after the submission was received.
What is the product code of K052296?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.