510(k) Report

FDA applicant

Vasca, Inc.

Tewksburt, MA2 decisions2000–20031 recall

FDA records 2 decisions for Vasca, Inc. (Tewksburt, MA) from 2000 to 2003: 2 510(k) clearances. All are in product code MSD (Catheter, Hemodialysis, Implanted). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, gastroenterology and urology panel, where it files most

How often FDA has decided Vasca, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vasca, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Vasca, 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?

  • MSDCatheter, Hemodialysis, Implanted2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K023023Lifesite Hemodialysis Access System, Cannula Exchange Kit, Insertion Kit, Access CannilaVasca, Inc. · 2003
  • K001633Lifesite Hemodialysis Access System/Cannula Exchange, Model LHAS14120 & LHCEK0000Vasca, Inc. · 20001 recall

All 2 as Vasca, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K001633LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000Sep 22, 2003