510(k) Report

FDA applicant

Boston Scientific Corporation Northwest Technology

Redmond, WA2 decisions1999–20000 recalls

FDA records 2 decisions for Boston Scientific Corporation Northwest Technology (Redmond, WA) from 1999 to 2000: 2 510(k) clearances. Most are in product codes MCW (Catheter, Peripheral, Atherectomy) and DQX (Wire, Guide, Catheter). Its devices cite 1 predicate, 0 of them its own earlier devices. No 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 Boston Scientific Corporation Northwest Technology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Boston Scientific Corporation Northwest Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Boston Scientific Corporation…’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?

  • MCWCatheter, Peripheral, Atherectomy1decision
  • DQXWire, Guide, Catheter1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K003398Wireclip TorquerBoston Scientific Corporation Northwest Technology · 20005cite it
  • K993648Rotablator Rotational Angioplasty System with the Rotalink Exchangeable CatheterBoston Scientific Corporation Northwest Technology · 19992cite it

What has FDA decided for it lately?

  • K003398Wireclip TorquerBoston Scientific Corporation Northwest Technology · 2000
  • K993648Rotablator Rotational Angioplasty System with the Rotalink Exchangeable CatheterBoston Scientific Corporation Northwest Technology · 1999

All 2 as Boston Scientific Corporation Northwest Technology →

Other applicant names beginning “Boston”

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

Boston Scientific Corp 809Boston Scientific Scimed, Inc. 40Boston Medical Products, Inc. 33Boston Scientific, Target 19Boston Surgical Products, Inc. 17Boston Biomedica, Inc. 12Boston Scientific Neuromodulation 11Boston Pacific Medical, Inc. 11Boston Medical Corp. 8Boston Aesthetics, Inc. 6The Boston Medical Group 5Boston Scientific/Medi-Tech 5