510(k) Report

FDA applicant

Medtronic Inc. Cardiac Rhythm Management

Minneapolis, MN2 decisions2004–20071 recall

FDA records 2 decisions for Medtronic Inc. Cardiac Rhythm Management (Minneapolis, MN) from 2004 to 2007: 2 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and DQX (Wire, Guide, Catheter). Its devices cite 7 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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 Inc. Cardiac Rhythm Management’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1, 1 Class I
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medtronic Inc. Cardiac Rhythm Management’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?

  • DQYCatheter, Percutaneous1decision
  • DQXWire, Guide, Catheter1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 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.

  • K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 20045cite it
  • K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management · 20071cites it

What has FDA decided for it lately?

  • K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management · 20071 Class I recall
  • K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004

All 2 as Medtronic Inc. Cardiac Rhythm Management →

What has been recalled?

1 recall linked to its devices; the latest:

  • K063210ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid…Oct 21, 2013Class I