510(k) Report

FDA applicant

Invatec S.P.A.

Bethlehem, PA4 decisions2009–20103 recalls

FDA records 4 decisions for Invatec S.P.A. (Bethlehem, PA) from 2009 to 2010: 4 510(k) clearances. Most are in product codes LIT (Catheter, Angioplasty, Peripheral, Transluminal) and FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 7 predicates, 0 of them its own earlier devices. 3 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, cardiovascular panel, where it files most

How often FDA has decided Invatec S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2009: 22010: 2
2009high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

3in 2023

2023: 3
2009high 3 (2023) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Invatec S.P.A. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Invatec S.P.A.’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?

  • LITCatheter, Angioplasty, Peripheral, Transluminal2decisions
  • FGEStents, Drains And Dilators For The Biliary Ducts1decision
  • NTETemporary Carotid Catheter For Embolic Capture1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K100921Admiral Xtreme Pta Balloon Dilatation CatheterInvatec S.P.A. · 20103cite it
  • K092361Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A. · 20092cite it

What has FDA decided for it lately?

  • K100921Admiral Xtreme Pta Balloon Dilatation CatheterInvatec S.P.A. · 2010
  • K092352Scuba Biliary Stent SystemInvatec S.P.A. · 2010
  • K092361Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A. · 2009
  • K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A. · 20093 recalls

All 4 as Invatec S.P.A. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K092177Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6Oct 12, 2023Class II
  • K092177Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6Oct 12, 2023Class II
  • K092177Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5Oct 12, 2023Class II

Other applicant names beginning “Invatec”

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

Invatec Innovative Technologies, S.R.L. 10