510(k) Report

FDA applicant

Stryker Neurovascular

Fremont, CA36 decisions2011–202646 recalls

FDA records 36 decisions for Stryker Neurovascular (Fremont, CA) from 2011 to 2026: 34 510(k) clearances and 2 original PMA approvals. Most are in product codes HCG (Device, Neurovascular Embolization) and QJP (Catheter, Percutaneous, Neurovasculature). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 44 predicates, 20 of them its own earlier devices. 46 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 Stryker Neurovascular’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2011: 22012: 32013: 22014: 12016: 32017: 12018: 12019: 52020: 32021: 42022: 12023: 12024: 22025: 42026 (partial year): 3
2011high 5 (2019) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2026

2013: 82014: 12016: 282017: 32023: 12024: 42026 (partial year): 1
2011high 28 (2016) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Stryker Neurovascular by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stryker Neurovascular’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?

  • HCGDevice, Neurovascular Embolization11decisions
  • QJPCatheter, Percutaneous, Neurovasculature10decisions
  • DQYCatheter, Percutaneous6decisions
  • POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment3decisions
  • NRYCatheter, Thrombus Retriever2decisions
  • MJNCatheter, Intravascular Occluding, Temporary1decision

Also: MOF (1), OUT (1), QCA (1).

How long do its 510(k) reviews take?

Since 2016, its 25 510(k)s took a median of 114 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 10 of its 25 were faster than that.

Whose devices does it build on?

Its devices cite 44 predicates; 20 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 39 times; 20 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.

  • K161429Target Detachable CoilsStryker Neurovascular · 20164cite it
  • K113778Excelsior XT-27 MicrocatheterStryker Neurovascular · 20124cite it
  • K160096InZone Detachment SystemStryker Neurovascular · 20163cite it
  • K153658Target Detachable CoilsStryker Neurovascular · 20163cite it
  • K112385Traget Detachable CoilStryker Neurovascular · 20113cite it
  • K190833AXS Vecta Aspiration CatheterStryker Neurovascular · 20192cite it

What has FDA decided for it lately?

  • K261649Excelsior Reach MicrocatheterStryker Neurovascular · 2026
  • K261889Trevo Trak 21 MicrocatheterStryker Neurovascular · 2026
  • K253032AXS Lift Intracranial Base CatheterStryker Neurovascular · 2026
  • K252694Target Detachable CoilStryker Neurovascular · 2025
  • K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular · 2025
  • K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter…Stryker Neurovascular · 2025
  • K243593AXS Lift Intracranial Base CatheterStryker Neurovascular · 2025
  • K241637Echo Intracranial Base CatheterStryker Neurovascular · 2024

All 36 as Stryker Neurovascular →

What has been recalled?

46 recalls linked to its devices; the latest:

  • K212455Inzone Detachment System, Ref: M00345100950Apr 6, 2026Class II
  • K211594The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness…Aug 30, 2024Class II
  • K211594Trevo Trak 21 Microcatheter, Catalog: 90338Apr 23, 2024Class II
  • K223305Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE…Apr 23, 2024Class II
  • K202522The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and…Apr 18, 2024Class II
  • K211594Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cmDec 6, 2023Class II

Other applicant names beginning “Stryker”

FDA records each applicant name separately; these may or may not be the same firm.

Stryker Corp. 354Stryker Endoscopy 103Stryker Instruments 77Stryker Spine 76Stryker Leibinger GmbH & Co KG 36Stryker Sustainability Solutions 34Stryker Trauma AG 32Stryker Orthopaedics 24Stryker Medical 14Stryker Instruments, Instruments Div. 6Stryker Corporate 6Stryker Corporation (Tornier, Inc.) 5