510(k) Report

FDA applicant

Medrad Interventional/Possis

Minneapolis, MN2 decisions2010–20111 recall

FDA records 2 decisions for Medrad Interventional/Possis (Minneapolis, MN) from 2010 to 2011: 2 510(k) clearances. All are in product code QEZ (Aspiration Thrombectomy Catheter). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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 Medrad Interventional/Possis’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 12011: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1, 1 Class I
2010high 1 (2016) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Medrad Interventional/Possis by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medrad Interventional/Possis’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?

  • QEZAspiration Thrombectomy Catheter2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K101406Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 20102cite it

What has FDA decided for it lately?

  • K101354Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 20111 Class I recall
  • K101406Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010

All 2 as Medrad Interventional/Possis →

What has been recalled?

1 recall linked to its devices; the latest:

  • K101354Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch…Mar 22, 2016Class I

Other applicant names beginning “Medrad”

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

Medrad, Inc. 105Medrad, Inc. / Bayer Medical Care, Inc. 2Medrad/Technology For People 1