510(k) Report

FDA applicant

Contego Medical, Inc.

Raleigh, NC8 decisions2018–20252 recalls

FDA records 8 decisions for Contego Medical, Inc. (Raleigh, NC) from 2018 to 2025: 7 510(k) clearances and 1 original PMA approval. Most are in product codes QEW (Peripheral Mechanical Thrombectomy With…) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Contego Medical, LLC”.

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

FDA decisions per year

1in 2025

2018: 22022: 22023: 22024: 12025: 1
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2026

2025: 12026 (partial year): 1
2018high 1 (2025) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Contego Medical, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Contego 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?

  • QEWPeripheral Mechanical Thrombectomy With Aspiration4decisions
  • LITCatheter, Angioplasty, Peripheral, Transluminal3decisions
  • NIMStent, Carotid1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 58 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 118 days; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K223897Excipio LV Thrombectomy DeviceContego Medical, Inc. · 20231cites it
  • K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)Contego Medical, LLC · 20181cites it
  • K221204Excipio SV Thrombectomy DeviceContego Medical, Inc. · 20221cites it

What has FDA decided for it lately?

  • K251485Excipio LV Prime Thrombectomy DeviceContego Medical, Inc. · 2025
  • P240009Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc. · 20242 recalls
  • K230030Excipio SV Aspiration Catheter and TubingContego Medical, Inc. · 2023
  • K223897Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023
  • K221204Excipio SV Thrombectomy DeviceContego Medical, Inc. · 2022
  • K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc. · 2022
  • K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC · 2018
  • K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)Contego Medical, LLC · 2018

All 6 as Contego Medical, Inc. →All 2 as Contego Medical, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P240009Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated…Jun 29, 2026Class II
  • P240009Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated…Sep 4, 2025Class II