510(k) Report

FDA applicant

Naltiac Medical, Inc.

Dallas, TX3 decisions1996–19960 recalls

FDA records 3 decisions for Naltiac Medical, Inc. (Dallas, TX) in 1996: 3 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DTL (Adaptor, Stopcock, Manifold, Fitting…). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Naltiac Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Naltiac Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Naltiac Medical, Inc. 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?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K961717Nmi Retrograde Cardioplegia Cannula-RCCSNaltiac Medical, Inc. · 1996
  • K961180Nmi Antegrad Cardioplegia CannulaNaltiac Medical, Inc. · 1996
  • K961181Nmi Vein Graft Perfusion SetNaltiac Medical, Inc. · 1996

All 3 as Naltiac Medical, Inc. →