Codan US Corp.
Santa Ana, CA, US
CODAN US CORP. appears in FDA device records in Santa Ana, CA. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Codan US Corp. between 1999 and 2012. The busiest year on record is 2002, with 2. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 2 |
| 2004 | 2 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112268 | CODAN SAFEFEED ENTERAL FEEDING RESERVOIR | KNT | Substantially Equivalent | |
| K042693 | IV ADMINISTRATION SET B400 SP | FPA | Substantially Equivalent | |
| K033301 | IV ADMINISTRATION AND CONNECT SETS | FPA | Substantially Equivalent | |
| K021480 | EXTENSION SET LIGHT-SAFE, MODEL BC565 | FPA | Substantially Equivalent | |
| K013714 | CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP | FPA | Substantially Equivalent | |
| K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 | FPA | Substantially Equivalent | |
| K990711 | CODAN CHEMOSPIKE | LHI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2016945 | 2016945 | CODAN US CORP. | 3501 WEST SUNFLOWER AVE., SANTA ANA, CA 92704 US | 2026 | |
| 3020417125 | 3020417125 | CODAN US Corporation | 2001 Sanyo Avenue Suite 130, San Diego, CA 92154 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2433-2020 | CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA. | Individual packages of connectors may have incomplete or bad seals which would compromise sterility. | Class II | Terminated | |
| Z-2040-2014 | ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS400-B (76.7801), CS408N-B (76.8001), CS3000-O (76.7808), CS400-O (76.7802), CS408N-O (76.8002), CS3000-G (76.7809), CS400-G (76.7803), CS408N-G (76.8004), CS3000-P (76.7810), CS400-P (76.7804), CS408N-P (76.8003). Intravenous administration sets | CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain