Lumend Percutaneous Catheter
FDA 510(k) K011562 · Lumend, Inc.
510(k) numberK011562
Submission
- Device name
- Lumend Percutaneous Catheter
- Applicant
- Lumend, Inc.
Redwood City, CA, US - Received
- May 21, 2001
- Decision date
- January 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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More from Abbott Medical
| 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 |
| 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 |
| K014117 | Modification to Outback CatheterDQY · Special | 01/11/2002SE |
| K001577 | Outback CatheterDQY · Traditional | 01/11/2001SE |
Questions and answers
When was Lumend Percutaneous Catheter cleared by the FDA?
Lumend Percutaneous Catheter (K011562) received a 510(k) decision of Substantially Equivalent on January 16, 2002, 240 days after the submission was received.
What is the product code of K011562?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.