510(k) Report

FDA applicant

Medtronic Cardiac Surgical Products

Grand Rapids, MI7 decisions2000–20036 recalls

FDA records 7 decisions for Medtronic Cardiac Surgical Products (Grand Rapids, MI) from 2000 to 2003: 7 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DRA (Catheter, Steerable). Its devices cite 6 predicates, 1 of them its own earlier devices. 6 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 Medtronic Cardiac Surgical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Cardiac Surgical Products since 2007.

Recalls per year

1in 2024

2011: 22014: 32024: 1
2007high 3 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medtronic Cardiac Surgical Products’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?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass6decisions
  • DRACatheter, Steerable1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 1 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.

  • K022272Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Medtronic Cardiac Surgical Products · 20032cite it
  • K000776Medtronic DLP Arterial Cannulae with 3D TipMedtronic Cardiac Surgical Products · 20012cite it
  • K010737Select Cap Arterial Cannula with Pressure Monitoring Line, Model…Medtronic Cardiac Surgical Products · 20012cite it
  • K000274Eopa Elongated One-Piece Arterial Cannula with GuidewireMedtronic Cardiac Surgical Products · 20002cite it
  • K013013Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 20012cite it

What has FDA decided for it lately?

  • K022272Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Medtronic Cardiac Surgical Products · 20033 recalls
  • K013013Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 20011 recall
  • K01214324 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524Medtronic Cardiac Surgical Products · 2001
  • K010737Select Cap Arterial Cannula with Pressure Monitoring Line, Model…Medtronic Cardiac Surgical Products · 20011 recall
  • K000776Medtronic DLP Arterial Cannulae with 3D TipMedtronic Cardiac Surgical Products · 20011 recall
  • K994171Medtronic Aortocoronary Shunt and Separately Packaged Arteriotomy CannulaeMedtronic Cardiac Surgical Products · 2000
  • K000274Eopa Elongated One-Piece Arterial Cannula with GuidewireMedtronic Cardiac Surgical Products · 2000

All 7 as Medtronic Cardiac Surgical Products →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K022272Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model…Mar 19, 2024Class II
  • K013013Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented…Jan 30, 2014Class II
  • K000776Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented…Jan 30, 2014Class II
  • K010737Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.)…Jan 30, 2014Class II
  • K022272Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula…Dec 14, 2011
  • K022272Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using…Dec 14, 2011