Lumend Frontrunner Cto Catheter
FDA 510(k) K023114 · Lumend, Inc.
510(k) numberK023114
Submission
- Device name
- Lumend Frontrunner Cto Catheter
- Applicant
- Lumend, Inc.
Redwood City, CA, US - Received
- September 19, 2002
- Decision date
- January 23, 2003
- 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 |
| 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 |
More from Ra Medical Systems,Inc
| 510(k) | Device | Decision |
|---|---|---|
| K043534 | Modification to Outback CatheterDQY · Special | 01/21/2005SE |
| K040771 | Modification to Outback CatheterDQY · Special | 04/23/2004SE |
| K033535 | Lumend Frontrunner Cto Catheter and AccessoriesPDU · Special | 01/07/2004SE |
| K032298 | Modification to Outback CatheterDQY · Special | 08/26/2003SE |
| K031005 | Lumend Frontrunner GW Cto CatheterPDU · Special | 06/18/2003SE |
| K023223 | Modification to Lumend Frontrunner Cto CatheterDQY · Special | 10/24/2002SE |
| K013284 | Lumend Frontrunner Cto Coronary CatheterDQY · Traditional | 02/11/2002SE |
| K011562 | Lumend Percutaneous CatheterDQY · Traditional | 01/16/2002SE |
| K014117 | Modification to Outback CatheterDQY · Special | 01/11/2002SE |
| K001577 | Outback CatheterDQY · Traditional | 01/11/2001SE |
Questions and answers
When was Lumend Frontrunner Cto Catheter cleared by the FDA?
Lumend Frontrunner Cto Catheter (K023114) received a 510(k) decision of Substantially Equivalent on January 23, 2003, 126 days after the submission was received.
What is the product code of K023114?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.