510(k) Report

FDA applicant

Intratherapeutics, Inc.

Saint Paul, MN15 decisions1998–200113 recalls

FDA records 15 decisions for Intratherapeutics, Inc. (Saint Paul, MN) from 1998 to 2001: 15 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and JCT (Prosthesis, Tracheal, Expandable). Its devices cite 21 predicates, 5 of them its own earlier devices. 13 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Intratherapeutics, Inc. since 2007.

Recalls per year

12in 2008

2008: 12
2007high 12 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts11decisions
  • JCTProsthesis, Tracheal, Expandable2decisions
  • DQYCatheter, Percutaneous2decisions

Whose devices does it build on?

Its devices cite 21 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 5 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.

  • K991929IntrastentIntratherapeutics, Inc. · 19993cite it
  • K003040Intrastent Protege Self-Expanding Nitinol Stent with Starport Delivery TechnologyIntratherapeutics, Inc. · 20003cite it
  • K980290Iti StentIntratherapeutics, Inc. · 19982cite it
  • K990221Intracoil Peripheral StentIntratherapeutics, Inc. · 19991cites it
  • K993904Intrastent Doublestrut LDIntratherapeutics, Inc. · 20001cites it
  • K001257Intracoil StentIntratherapeutics, Inc. · 20001cites it

What has FDA decided for it lately?

  • K011184Intrastent Doublestrut Paramount XS Biliary EndoprosthesisIntratherapeutics, Inc. · 2001
  • K003997Intrastent Doublestrut Paramount XS Biliary EndoprosthesisIntratherapeutics, Inc. · 2001
  • K003040Intrastent Protege Self-Expanding Nitinol Stent with Starport Delivery TechnologyIntratherapeutics, Inc. · 2000
  • K003450Intrastent Doublestrut Paramount Biliary EndoprosthesisIntratherapeutics, Inc. · 2000
  • K001648Intrastent Doublestrut ParamountIntratherapeutics, Inc. · 2000
  • K001257Intracoil StentIntratherapeutics, Inc. · 2000
  • K000864Intrastent Doublestrut XS StentIntratherapeutics, Inc. · 2000
  • K993904Intrastent Doublestrut LDIntratherapeutics, Inc. · 20001 recall

All 15 as Intratherapeutics, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K980290ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, ev3, 4600…Jan 18, 2008
  • K980290ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, ev3, 4600 Nathan Lane…Jan 18, 2008
  • K980290ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane…Jan 18, 2008
  • K980290ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600…Jan 18, 2008
  • K980290ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, ev3, 4600…Jan 18, 2008
  • K980290ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, ev3…Jan 18, 2008