Lumend Frontrunner GW Cto Catheter
FDA 510(k) K031005 · Lumend, Inc.
510(k) numberK031005
Submission
- Device name
- Lumend Frontrunner GW Cto Catheter
- Applicant
- Lumend, Inc.
Redwood City, CA, US - Received
- March 31, 2003
- Decision date
- June 18, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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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 |
| K023114 | Lumend Frontrunner Cto CatheterPDU · Traditional | 01/23/2003SE |
| 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 GW Cto Catheter cleared by the FDA?
Lumend Frontrunner GW Cto Catheter (K031005) received a 510(k) decision of Substantially Equivalent on June 18, 2003, 79 days after the submission was received.
What is the product code of K031005?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.