Catheter Innovations, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Catheter Innovations, Inc. makes
Catheter Innovations, Inc. manufactures peripherally inserted central catheters (PICCs) and midline catheters, including dual-lumen designs with passive valve technology, as well as implantable ports and extension sets for intravenous access. Their product line includes passive-valve-equipped PICCs, dual-lumen midline catheters, and specialized extension sets for bone marrow or other high-flow applications. Additional offerings include placement aids and implantable ports for long-term venous access.
The company’s devices are classified under FDA Class II and are listed via 510(k) clearance in the United States. Their portfolio is regulated under the US Food and Drug Administration’s medical device authority, with no mention of other jurisdictions. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Dual Lumen Midline Catheter Ref K010349
Regimes: 510(k) Registry: 510(k)Placement-Plus Ref K003642
Regimes: 510(k) Registry: 510(k)Vaxcel Picc With Pasv Valve Technology Ref K021704
Regimes: 510(k) Registry: 510(k)Catheter Innovations Implantable Port Ref K993860
Regimes: 510(k) Registry: 510(k)Catheter Innovations Implantable Port Ref K991897
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Catheter Innovations, Inc. have in the registry?
The registry currently lists 8 devices for Catheter Innovations, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Catheter Innovations, Inc.'s devices?
Among its 8 most recently registered devices, Catheter Innovations, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Catheter Innovations, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Catheter Innovations, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Catheter Innovations, Inc. in the registry?
The most recently registered devices listed for Catheter Innovations, Inc. include PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS, PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS, 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT and DUAL LUMEN MIDLINE CATHETER.