510(k) Report

FDA applicant

Daig Corp.

Minnetonka, MN63 decisions1977–200015 recalls

FDA records 63 decisions for Daig Corp. (Minnetonka, MN) from 1977 to 2000: 63 510(k) clearances. Most are in product codes DTB (Permanent Pacemaker Electrode) and DYB (Introducer, Catheter). Its devices cite 3 predicates, 3 of them its own earlier devices. 15 recalls are 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 Daig Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Daig Corp. since 2007.

Recalls per year

2in 2019

2009: 52012: 12014: 22019: 2
2007high 5 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Daig Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DTBPermanent Pacemaker Electrode28decisions
  • DYBIntroducer, Catheter18decisions
  • DQOCatheter, Intravascular, Diagnostic4decisions
  • LDFElectrode, Pacemaker, Temporary3decisions
  • DTDPacemaker Lead Adaptor3decisions
  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording3decisions

Also: DRA (1), DQR (1), DSA (1), DRE (1).

Who builds on its devices?

Later devices cite its devices 44 times; 3 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.

  • K964518Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 19979cite it
  • K894500Daig Electrophysiology CatheterDaig Corp. · 19897cite it
  • K942379Daig Diagnostic Electrophysiology CatheterDaig Corp. · 19946cite it
  • K913940Response (TM) Steerable CatheterDaig Corp. · 19934cite it
  • K973840Fast-Cath (TM) Intra-Cardiac IntroducerDaig Corp. · 19983cite it
  • K894343Daig Percutaneous Catheter Intro. & Removable HemoDaig Corp. · 19892cite it

What has FDA decided for it lately?

  • K000004Alliance Left Heart Delivery System Introducer, Model #407509Daig Corp. · 2000
  • K994334Ultra-Flex Hemostasis Introducer. Model 406XXXDaig Corp. · 2000
  • K982299Spyglass 5 FR Angiographic CatheterDaig Corp. · 1998
  • K982187Fast-Cath Intra-Cardiac IntroducerDaig Corp. · 19982 recalls
  • K973840Fast-Cath (TM) Intra-Cardiac IntroducerDaig Corp. · 19982 recalls
  • K964518Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 19974 recalls
  • K965249Spyglass Angiographic CatheterDaig Corp. · 1997
  • K962805Spyglass Angiographic CatheterDaig Corp. · 1996

All 63 as Daig Corp. →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K954317Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303Dec 9, 2019Class II
  • K914090Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 -…Dec 9, 2019Class II
  • K954317St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO.…Oct 14, 2014Class II
  • K894500St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353Oct 14, 2014Class II
  • K964518Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO…Mar 28, 2012Class III
  • K870562Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized…Sep 1, 2009