Modification to Outback Catheter
FDA 510(k) K043534 · Lumend, Inc.
510(k) numberK043534
Submission
- Device name
- Modification to Outback Catheter
- Applicant
- Lumend, Inc.
Redwood City, CA, US - Received
- December 22, 2004
- Decision date
- January 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| 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 |
| 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 Modification to Outback Catheter cleared by the FDA?
Modification to Outback Catheter (K043534) received a 510(k) decision of Substantially Equivalent on January 21, 2005, 30 days after the submission was received.
What is the product code of K043534?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.