Catheter Connections, Inc.
Park City, UT, US
Catheter Connections, Inc. appears in FDA device records in Park City, UT. FDA records list 7 510(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 7 510(k) clearances for Catheter Connections, Inc. between 2010 and 2015. The busiest year on record is 2012, with 2. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142806 | DualCap | QBP | Substantially Equivalent | |
| K142399 | DualCap IV Pole Strips(Disinfectant Caps for Male Luers) | QBP | Substantially Equivalent | |
| K123967 | CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS | QBP | Substantially Equivalent | |
| K123065 | CATHETER CONNECTIONS DUALCAP SOLO | QBP | Substantially Equivalent | |
| K113842 | CATHETER CONNECTIONS' DUALCAP SOLO | QBP | Substantially Equivalent | |
| K112985 | CATHETER CONNECTIONS' DUALCAP DUO | QBP | Substantially Equivalent | |
| K093229 | CATHETER CONNECTIONS DUALCAP | QBP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2595-2014 | DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed. | Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain