Catheter Connections, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Catheter Connections, Inc. makes
Catheter Connections, Inc. manufactures dual-cap connectors for intravenous (IV) lines, including male luer lock systems with disinfectant caps. Their products include standalone dual-cap connectors, IV pole strips with disinfectant caps, and colored dual-cap variants for male luer fittings, designed to reduce contamination risk during IV therapy.
These devices are classified as Class II under US regulations and are listed via FDA 510(k) clearance. The company operates from the United States, adhering to US regulatory requirements for medical device authorisation.
Catalogue
Catheter Connections Dualcap Solo Ref K123065
Regimes: 510(k) Registry: 510(k)Catheter Connections' Dualcap Solo Ref K113842
Regimes: 510(k) Registry: 510(k)Catheter Connections' Dualcap Duo Ref K112985
Regimes: 510(k) Registry: 510(k)Catheter Connections Dualcap Ref K093229
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
DualCap Ref K142806
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Catheter Connections, Inc., initiated on 2014-08-05. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 5 Aug 2014 Z-2595-2014 Class II Terminated 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.
Frequently asked questions
How many devices does Catheter Connections, Inc. have in the registry?
The registry currently lists 7 devices for Catheter Connections, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Catheter Connections, Inc.'s devices?
Among its 7 most recently registered devices, Catheter Connections, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Catheter Connections, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Catheter Connections, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Catheter Connections, Inc.?
FDA recall records list 1 recall initiated by Catheter Connections, Inc., the most recent initiated on 5 Aug 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Catheter Connections, Inc. in the registry?
The most recently registered devices listed for Catheter Connections, Inc. include CATHETER CONNECTIONS DUALCAP SOLO, CATHETER CONNECTIONS' DUALCAP SOLO, CATHETER CONNECTIONS' DUALCAP DUO and CATHETER CONNECTIONS DUALCAP.