510(k) Report

FDA applicant

Catheter Innovations, Inc.

Salt Lake City, UT8 decisions1998–200240 recalls

FDA records 8 decisions for Catheter Innovations, Inc. (Salt Lake City, UT) from 1998 to 2002: 8 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and LJT (Port & Catheter, Implanted, Subcutaneous…). Its devices cite 6 predicates, 1 of them its own earlier devices. 40 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Catheter Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Catheter Innovations, Inc. since 2007.

Recalls per year

23in 2016

2016: 23
2007high 23 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Catheter Innovations, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Catheter Innovations, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days3decisions
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K021704Vaxcel Picc with Pasv Valve TechnologyCatheter Innovations, Inc. · 20024cite it
  • K991897Catheter Innovations Implantable PortCatheter Innovations, Inc. · 19991cites it

What has FDA decided for it lately?

  • K021704Vaxcel Picc with Pasv Valve TechnologyCatheter Innovations, Inc. · 200231 recalls
  • K010349Dual Lumen Midline CatheterCatheter Innovations, Inc. · 2001
  • K003642Placement-PlusCatheter Innovations, Inc. · 2000
  • K993860Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999
  • K991897Catheter Innovations Implantable PortCatheter Innovations, Inc. · 19999 recalls
  • K981382Pasv Dual Lumen Peripherally Inserted Midline Catheter Model Number Midline-NumerousCatheter Innovations, Inc. · 1998
  • K981368Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model Number Pic-NumerousCatheter Innovations, Inc. · 1998
  • K9801276 Inch Mini-Bone Extension Set with Luer Lock, NES01S, 6 Inch Min-Bone Extension Set with Luer Slip, NES02S…Catheter Innovations, Inc. · 1998

All 8 as Catheter Innovations, Inc. →

What has been recalled?

40 recalls linked to its devices; the latest:

  • K021704BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN…Mar 14, 2016Class II
  • K021704BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 &…Mar 14, 2016Class II
  • K021704Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx…Mar 14, 2016Class II
  • K021704Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910…Mar 14, 2016Class II
  • K021704Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN…Mar 14, 2016Class II
  • K021704Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx…Mar 14, 2016Class II

Other applicant names beginning “Catheter”

FDA records each applicant name separately; these may or may not be the same firm.

Catheter Technology Corp. 13Catheter Research, Inc. 8Catheter Research C/O Burditt, Bowles & Radzius 8Catheter Connections, Inc. 7Catheter Robotics, Inc. 3Catheter Precision, Inc. 2Catheter Sciences Co. 2The Catheter Exchange, Inc. 1Catheter, LLC 1Catheter Corp. of America 1