Company ยท US
Lumend, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2005. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 21, 2005 | K043534 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc. | DQY |
| Apr 23, 2004 | K040771 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc. | DQY |
| Jan 7, 2004 | K033535 | LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES Lumend, Inc. | PDU |
| Aug 26, 2003 | K032298 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc. | DQY |
| Jun 18, 2003 | K031005 | LUMEND FRONTRUNNER GW CTO CATHETER Lumend, Inc. | PDU |
| Jan 23, 2003 | K023114 | LUMEND FRONTRUNNER CTO CATHETER Lumend, Inc. | PDU |
| Oct 24, 2002 | K023223 | MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER Lumend, Inc. | DQY |
| Feb 11, 2002 | K013284 | LUMEND FRONTRUNNER CTO CORONARY CATHETER Lumend, Inc. | DQY |
| Jan 16, 2002 | K011562 | LUMEND PERCUTANEOUS CATHETER Lumend, Inc. | DQY |
| Jan 11, 2002 | K014117 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc. | DQY |
| Jan 11, 2001 | K001577 | OUTBACK CATHETER Lumend, Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Lumend Inc LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas. Terminated |
DQY | K032298 |