510(k) Report

FDA applicant

Intensive Technology, Inc.

San Diego, CA13 decisions1981–19931 recall

FDA records 13 decisions for Intensive Technology, Inc. (San Diego, CA) from 1981 to 1993: 12 510(k) clearances and 1 original PMA approval. Most are in product codes DQX (Wire, Guide, Catheter) and DYB (Introducer, Catheter). 1 recall is 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 Intensive Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intensive Technology, Inc. since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Intensive Technology, 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?

  • DQXWire, Guide, Catheter2decisions
  • DYBIntroducer, Catheter2decisions
  • LITCatheter, Angioplasty, Peripheral, Transluminal2decisions
  • MCXCatheter, Coronary, Atherectomy1decision
  • JJSControls For Blood-Gases, (Assayed And Unassayed)1decision
  • GFOActivated Partial Thromboplastin1decision

Also: DWX (1), KFF (1), MCW (1), DQY (1).

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K8828040.014 Peripheral Guide WireIntensive Technology, Inc. · 19882cite it
  • K895903Ivt 0.014 Guide WireIntensive Technology, Inc. · 19902cite it
  • K890515Peripheral Atherectomy SystemIntensive Technology, Inc. · 19891cites it
  • K922970Intra-Operative Tec Atherectomy SystemIntensive Technology, Inc. · 19931cites it
  • K911869Ivt Guiding CatheterIntensive Technology, Inc. · 19911cites it

What has FDA decided for it lately?

  • P910019Ivt Coronary Atherectomy System (Tec)(R)Intensive Technology, Inc. · 1993
  • K922970Intra-Operative Tec Atherectomy SystemIntensive Technology, Inc. · 1993
  • K912664Tec Rotating Dual HemovalveIntensive Technology, Inc. · 1992
  • K911869Ivt Guiding CatheterIntensive Technology, Inc. · 1991
  • K903463Ivt Introducer SheathIntensive Technology, Inc. · 1991
  • K904003Hemochron (R) Heparin Response TestIntensive Technology, Inc. · 19901 recall
  • K901767Modified Ivt Peripheral AtherectomyIntensive Technology, Inc. · 1990
  • K896403Modified Ivt Peripheral Atherectomy SystemIntensive Technology, Inc. · 1990

All 13 as Intensive Technology, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K904003RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and…Jun 24, 2010