FDA applicant

Intra Special Catheters GmbH

Palm Harobor, FL1 decision1996–19960 recalls

FDA records 1 decision for Intra Special Catheters GmbH (Palm Harobor, FL) in 1996: 1 510(k) clearance. All are in product code GBX (Catheter, Irrigation). 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, general and plastic surgery panel, where it files most

How often FDA has decided Intra Special Catheters GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intra Special Catheters GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intra Special Catheters GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Intra”

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

Intra Luminal Therapeutics, Inc. 20 Intra-Lock International 13 Intra Lase Corp. 9 Intra Vantage, Inc. 1 Intra-Sonix, Inc. 1 Intra-Optics Labs. C/O Newman Assoc. 1

Intra Special Catheters GmbH

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Intra”