Kalila Medical, Inc.
Campbell, CA, US
Kalila Medical, Inc. appears in FDA device records in Campbell, CA. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Kalila Medical, Inc. between 2014 and 2017. The busiest year on record is 2017, with 2. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2017 | 2 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0564-2018 | Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA. | Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process. | Class II | Terminated | |
| Z-0563-2018 | Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA. | Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain