Lumend, Inc.
Redwood City, CA, US
Lumend, Inc. appears in FDA device records in Redwood City, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Lumend, Inc. between 2001 and 2005. The busiest year on record is 2002, with 4. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 4 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K043534 | MODIFICATION TO OUTBACK CATHETER | DQY | Substantially Equivalent | |
| K040771 | MODIFICATION TO OUTBACK CATHETER | DQY | Substantially Equivalent | |
| K033535 | LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES | PDU | Substantially Equivalent | |
| K032298 | MODIFICATION TO OUTBACK CATHETER | DQY | Substantially Equivalent | |
| K031005 | LUMEND FRONTRUNNER GW CTO CATHETER | PDU | Substantially Equivalent | |
| K023114 | LUMEND FRONTRUNNER CTO CATHETER | PDU | Substantially Equivalent | |
| K023223 | MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER | DQY | Substantially Equivalent | |
| K013284 | LUMEND FRONTRUNNER CTO CORONARY CATHETER | DQY | Substantially Equivalent | |
| K011562 | LUMEND PERCUTANEOUS CATHETER | DQY | Substantially Equivalent | |
| K014117 | MODIFICATION TO OUTBACK CATHETER | DQY | Substantially Equivalent | |
| K001577 | OUTBACK CATHETER | DQY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0995-04 | LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas. | Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain