510(k) Report

FDA applicant

Invatec Innovative Technologies, S.R.L.

Plymouth, MN10 decisions2004–20092 recalls

FDA records 10 decisions for Invatec Innovative Technologies, S.R.L. (Plymouth, MN) from 2004 to 2009: 10 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and QEZ (Aspiration Thrombectomy Catheter). Its devices cite 16 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Invatec Innovative Technologies”.

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 Innovative Technologies, S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2009: 12015: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Invatec Innovative Technologies, S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Invatec Innovative Technologies, S.R.L.’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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Other applicant names beginning “Invatec”

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