510(k) Report

FDA applicant

Scimed Peripheral Interventions

Plymouth, MN8 decisions1993–19950 recalls

FDA records 8 decisions for Scimed Peripheral Interventions (Plymouth, MN) from 1993 to 1995: 8 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Scimed Peripheral Interventions’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scimed Peripheral Interventions since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DQXWire, Guide, Catheter4decisions
  • LITCatheter, Angioplasty, Peripheral, Transluminal2decisions
  • KRACatheter, Continuous Flush1decision
  • DQYCatheter, Percutaneous1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K945904Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 19951cites it
  • K934359Scimed Strike Steerable Guide WireScimed Peripheral Interventions · 19931cites it
  • K934122Scimed Transend EX Steerable Guide Wire and AccessoriesScimed Peripheral Interventions · 19931cites it

What has FDA decided for it lately?

  • K945904Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
  • K946272Scimed (R) Courier Guide CatheterScimed Peripheral Interventions · 1995
  • K944677Scimed Transent EX Steerable Guide Wire and AccessoriesScimed Peripheral Interventions · 1995
  • K941710Scimed Transend Steerable Guide Wire and AccessoriesScimed Peripheral Interventions · 1994
  • K935501Scimed Viper Pta Catheter with Bioslide Hydrophilic CoatingScimed Peripheral Interventions · 1994
  • K934793Scimed MaverickScimed Peripheral Interventions · 1994
  • K934359Scimed Strike Steerable Guide WireScimed Peripheral Interventions · 1993
  • K934122Scimed Transend EX Steerable Guide Wire and AccessoriesScimed Peripheral Interventions · 1993

All 8 as Scimed Peripheral Interventions →

Other applicant names beginning “Scimed”

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

Scimed Life Systems, Inc. 111Scimed 8