510(k) Report

FDA applicant

Cordis Neurovascular, Inc.

Miami Lakes, FL38 decisions1994–20084 recalls

FDA records 38 decisions for Cordis Neurovascular, Inc. (Miami Lakes, FL) from 1994 to 2008: 38 510(k) clearances. Most are in product codes KRA (Catheter, Continuous Flush) and HCG (Device, Neurovascular Embolization). Its devices cite 52 predicates, 23 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Cordis Neurovascular”.

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 Cordis Neurovascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007: 22008: 2
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2008

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

Class I Class II/III not classified

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

Planning a device like Cordis Neurovascular, Inc.’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?

  • KRACatheter, Continuous Flush13decisions
  • HCGDevice, Neurovascular Embolization13decisions
  • DQXWire, Guide, Catheter4decisions
  • DQYCatheter, Percutaneous4decisions
  • DQOCatheter, Intravascular, Diagnostic3decisions
  • DXCClamp, Vascular1decision

Whose devices does it build on?

Its devices cite 52 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 55 times; 23 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.

  • K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc. · 20025cite it
  • K965181Ces Infusion CatheterCordis Neurovascular, Inc. · 19975cite it
  • K972518Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 19975cite it
  • K983483Vascular Occlusion SystemCordis Neurovascular, Inc. · 19994cite it
  • K991646Agility Steerable GuidewireCordis Neurovascular, Inc. · 19993cite it
  • K964367Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 19973cite it

What has FDA decided for it lately?

  • K082324Trufill DCS SyringeCordis Neurovascular, Inc. · 2008
  • K080967Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known as the…Cordis Neurovascular, Inc. · 2008
  • K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc. · 2007
  • K070279Modification to Hypertransit Infusion CatheterCordis Neurovascular, Inc. · 2007
  • K063254The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil SystemCordis Neurovascular, Inc. · 2006
  • K053197Trufill DCS Orbit Detachable Coil System Line ExtensionCordis Neurovascular, Inc. · 2005
  • K043538Hypertransit Infusion CatheterCordis Neurovascular, Inc. · 2005
  • K032553Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as Trufill DCS Orbit Detachable Coil…Cordis Neurovascular, Inc. · 2003

All 37 as Cordis Neurovascular, Inc. →The one decision as Cordis Neurovascular →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K983003MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to…Jun 30, 2008
  • K021591Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.Aug 11, 2006
  • K021591Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.Aug 11, 2006
  • K003925Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal…Oct 19, 2001

Other applicant names beginning “Cordis”

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

Cordis Corp. 334Cordis US Corporation 12Cordis Corp., A Johnson & Johnson Co. 11Cordis Webster, Inc. 10Cordis Europa, N.V. 7Cordis Leads, Inc. 4Cordis, A Cardinal Health Company 1