510(k) Report

FDA applicant

Microvena Corp.

White Bear Lake, MN18 decisions1990–19992 recalls

FDA records 18 decisions for Microvena Corp. (White Bear Lake, MN) from 1990 to 1999: 18 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 12 predicates, 7 of them its own earlier devices. 2 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 Microvena Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Microvena Corp. since 2007.

Recalls per year

1in 2007

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

Class I Class II/III not classified

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

Planning a device like Microvena Corp.’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?

  • DQXWire, Guide, Catheter8decisions
  • DQYCatheter, Percutaneous3decisions
  • MCWCatheter, Peripheral, Atherectomy3decisions
  • DXECatheter, Embolectomy2decisions
  • DREDilator, Vessel, For Percutaneous Catheterization1decision
  • DYBIntroducer, Catheter1decision

Whose devices does it build on?

Its devices cite 12 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 7 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.

  • K972511Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 19987cite it
  • K970668The Amplantz Goose Neck MicrosnareMicrovena Corp. · 19985cite it
  • K910280Ultra-Select Ptca GuidewireMicrovena Corp. · 19913cite it
  • K952860The Niner Nitinol GuidewireMicrovena Corp. · 19952cite it
  • K922060.25' Ultra-Select GuidewireMicrovena Corp. · 19932cite it
  • K925439MicrosnareMicrovena Corp. · 19932cite it

What has FDA decided for it lately?

  • K991898Ultra-Select Guidewire, Hytek GuidewireMicrovena Corp. · 1999
  • K991194Modification to Ultra-Select GuidewireMicrovena Corp. · 1999
  • K982657Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model AK 100Microvena Corp. · 1998
  • K970668The Amplantz Goose Neck MicrosnareMicrovena Corp. · 1998
  • K972511Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 19981 recall
  • K971984Amplatz Thrombectomy Device (Atd 603,602,801,802)/Foot Pedal Assembly (AK 200)Microvena Corp. · 1997
  • K954642Hydro-Select GuidewireMicrovena Corp. · 1996
  • K954205The Amplatz Thrombectomy DeviceMicrovena Corp. · 1996

All 18 as Microvena Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K972511Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile…May 18, 2007
  • K901502Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x…Aug 16, 2005