510(k) Report

FDA applicant

Enpath Medical, Inc.

Minneapolis, MN7 decisions2004–20085 recalls

FDA records 7 decisions for Enpath Medical, Inc. (Minneapolis, MN) from 2004 to 2008: 7 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 8 predicates, 2 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Enpath Medical Incorporated”.

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 Enpath Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 22008: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

3in 2016

2016: 3
2007high 3 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Enpath 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?

  • DYBIntroducer, Catheter5decisions
  • DQYCatheter, Percutaneous2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 2 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.

  • K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 20074cite it
  • K043489Enpath Deflectable CatheterEnpath Medical Incorporated · 20053cite it
  • K061119Enpath Medical Steerable SheathEnpath Medical, Inc. · 20063cite it
  • K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc. · 20062cite it
  • K081394Ptfe Interlock Peelable IntroducersEnpath Medical, Inc. · 20081cites it

What has FDA decided for it lately?

  • K081394Ptfe Interlock Peelable IntroducersEnpath Medical, Inc. · 2008
  • K072248Viapeel Peelable IntroducerEnpath Medical, Inc. · 20071 recall
  • K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 20072 recalls
  • K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc. · 2006
  • K061119Enpath Medical Steerable SheathEnpath Medical, Inc. · 2006
  • K043489Enpath Deflectable CatheterEnpath Medical Incorporated · 20052 recalls
  • K041708Enpath Safety IntroducerEnpath Medical Incorporated · 2004

All 5 as Enpath Medical, Inc. →All 2 as Enpath Medical Incorporated →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K072248ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006Nov 11, 2016Class II
  • K071574MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath…Sep 8, 2016Class II
  • K071574Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial…Sep 8, 2016Class II
  • K043489Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US…Jun 27, 2006
  • K043489Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical…Aug 31, 2005