510(k) Report

FDA applicant

Plastimed Laboratoire Pharmaceutique

Cedex, FR2 decisions1998–20006 recalls

FDA records 2 decisions for Plastimed Laboratoire Pharmaceutique (Cedex, FR) from 1998 to 2000: 2 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and EOQ (Bronchoscope (Flexible Or Rigid)). Its devices cite 3 predicates, 0 of them its own earlier devices. 6 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 Plastimed Laboratoire Pharmaceutique’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Plastimed Laboratoire Pharmaceutique since 2007.

Recalls per year

6in 2020

2020: 6
2007high 6 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Plastimed Laboratoire Pharmaceutique 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?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1decision
  • EOQBronchoscope (Flexible Or Rigid)1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K974642Combicath CatheterPlastimed Laboratoire Pharmaceutique · 19982cite it
  • K992424Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 & 63246J20Plastimed Laboratoire Pharmaceutique · 20001cites it

What has FDA decided for it lately?

  • K992424Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 & 63246J20Plastimed Laboratoire Pharmaceutique · 2000
  • K974642Combicath CatheterPlastimed Laboratoire Pharmaceutique · 19986 recalls

All 2 as Plastimed Laboratoire Pharmaceutique →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K974642Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x…May 27, 2020Class II
  • K974642Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial…May 27, 2020Class II
  • K974642Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-…May 27, 2020Class II
  • K974642Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial…May 27, 2020Class II
  • K974642Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-"…May 27, 2020Class II
  • K974642Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x…May 27, 2020Class II