Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console
FDA 510(k) K140185 · Avinger, Inc.
510(k) numberK140185
Submission
- Device name
- Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console
- Applicant
- Avinger, Inc.
Redwood City, CA, US - Received
- January 24, 2014
- Decision date
- May 1, 2014
- 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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| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
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| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…MCW · Special | 10/30/2017SE |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledMCW · Special | 12/21/2016SE |
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Questions and answers
When was Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console cleared by the FDA?
Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console (K140185) received a 510(k) decision of Substantially Equivalent on May 1, 2014, 97 days after the submission was received.
What is the product code of K140185?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.