510(k) Report

FDA applicant

Diag Corp.

Minnetonka, MN9 decisions1980–19990 recalls

FDA records 9 decisions for Diag Corp. (Minnetonka, MN) from 1980 to 1999: 9 510(k) clearances. Most are in product codes DTB (Permanent Pacemaker Electrode) and DYB (Introducer, Catheter). Its devices cite 1 predicate, 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 Diag Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diag Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diag Corp. 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?

  • DTBPermanent Pacemaker Electrode5decisions
  • DYBIntroducer, Catheter2decisions
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision
  • LDFElectrode, Pacemaker, Temporary1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K910645Disposable Patient CableDiag Corp. · 19911cites it

What has FDA decided for it lately?

  • K984062Seal-Away Hemostasis Adapter, Model 406229Diag Corp. · 1999
  • K911883Daig Fast Cath (TM) Transseptal Sheath IntroducerDiag Corp. · 1991
  • K910645Disposable Patient CableDiag Corp. · 1991
  • K852446Endocardial Screw-in Lead with Platinum Porous TipDiag Corp. · 1985
  • K820003Cardiovascular Temp. Pacemaker ElecDiag Corp. · 1982
  • K820262Permanent & Temporary Pacemaker Electr.Diag Corp. · 1982
  • K812905Permanent Endocard. Unipolar Tined LeadDiag Corp. · 1982
  • K812270Perm. Endocardial Unipolar Tined AtrialDiag Corp. · 1981

All 9 as Diag Corp. →