510(k) Report

FDA applicant

Medtronic Vascular

Minneapolis, MN500 decisions1977–2023366 recalls

FDA records 500 decisions for Medtronic Vascular (Minneapolis, MN) from 1977 to 2023: 480 510(k) clearances and 20 original PMA approvals. Most are in product codes DTB (Permanent Pacemaker Electrode) and DXY (Implantable Pacemaker Pulse-Generator). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 235 predicates, 82 of them its own earlier devices. 366 recalls are linked to its devices, 195 Class I.

FDA’s records also spell it “Medtronic Vascular, Inc.”.

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 Vascular’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2007: 62008: 32009: 32010: 32011: 12012: 22013: 32014: 12015: 12016: 42017: 42018: 22019: 22020: 12022: 12023: 3
2007high 6 (2007) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007: 42008: 112009: 32010: 22011: 12012: 12013: 4, 1 Class I2014: 32015: 52016: 32017: 3, 1 Class I2018: 22019: 191, 191 Class I2021: 14, 2 Class I2022: 22023: 12024: 12025: 12026 (partial year): 1
2007high 191 (2019) · low 0 (2020)2026

Class I Class II/III not classified

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

Planning a device like Medtronic Vascular’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?

  • DTBPermanent Pacemaker Electrode69decisions
  • DXYImplantable Pacemaker Pulse-Generator59decisions
  • GZBStimulator, Spinal-Cord, Implanted (Pain Relief)56decisions
  • DQYCatheter, Percutaneous31decisions
  • LDFElectrode, Pacemaker, Temporary21decisions
  • DTDPacemaker Lead Adaptor19decisions

Also: DXH (15), DTZ (12), GZJ (10), GXY (10), GZF (8), DYB (7).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 111 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 3 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 235 predicates; 82 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 303 times; 82 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.

  • K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880Medtronic Vascular · 200212cite it
  • K933586Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive SurfaceMedtronic Vascular · 19948cite it
  • K021589Attain Access 6218A Left-Heart Delivery System, Model 6218Medtronic Vascular · 20028cite it
  • K061958Medtronic Export XT CatheterMedtronic Vascular · 20067cite it
  • K0227647F Launcher Guide CatheterMedtronic Vascular · 20027cite it
  • K012083Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 20017cite it

What has FDA decided for it lately?

  • K232570Steerant™ Super Stiff GuidewireMedtronic Vascular · 2023
  • K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterMedtronic Vascular · 2023
  • K2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide CatheterMedtronic Vascular · 2023
  • K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock…Medtronic Vascular · 2022
  • P200026Abre Venous Self-expanding Stent SystemMedtronic Vascular, Inc. · 20203 recalls
  • P190008IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterMedtronic Vascular, Inc. · 20191 recall
  • K192296Medtronic 6F Taiga Guiding CatheterMedtronic Vascular · 2019
  • K182957Heli-FX EndoAnchor SystemMedtronic Vascular, Inc. · 2018

All 488 as Medtronic Vascular →All 12 as Medtronic Vascular, Inc. →

What has been recalled?

366 recalls linked to its devices; the latest:

  • K024069Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010…May 25, 2026Class II
  • P200026Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090…Dec 4, 2025Class II
  • K024069DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)Dec 12, 2024Class II
  • P110023Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80…Nov 20, 2023Class II
  • P110023EverFlex Self-Expanding Peripheral Stent with Entrust Delivery SystemJul 14, 2022Class II
  • P190008Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile…Mar 23, 2022Class II