510(k) Report

FDA applicant

Nmt Medical, Inc.

Marietta, GA3 decisions2000–20040 recalls

FDA records 3 decisions for Nmt Medical, Inc. (Marietta, GA) from 2000 to 2004: 2 510(k) clearances and 1 original PMA approval. Most are in product codes HCI (Applier, Aneurysm Clip) and DYB (Introducer, Catheter). Its devices cite 4 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 Nmt Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nmt Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nmt Medical, Inc.’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?

  • HCIApplier, Aneurysm Clip1decision
  • DYBIntroducer, Catheter1decision
  • MLVTranscatheter Septal Occluder1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K034025NMT Medical Transseptal Sheath Set, Models TSS-10-HSC, TSS-11-HSC, TSS12-HSCNmt Medical, Inc. · 20041cites it

What has FDA decided for it lately?

  • K034025NMT Medical Transseptal Sheath Set, Models TSS-10-HSC, TSS-11-HSC, TSS12-HSCNmt Medical, Inc. · 2004
  • P000049Cardioseal Septal Occlusion System with QwikloadNmt Medical, Inc. · 2001
  • K994191Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754TNmt Medical, Inc. · 2000

All 3 as Nmt Medical, Inc. →