510(k) Report

FDA applicant

Map Medical Equipment, Inc.

North Lawrence, NY1 decision1996–19962 recalls

FDA records 1 decision for Map Medical Equipment, Inc. (North Lawrence, NY) in 1996: 1 510(k) clearance. All are in product code DQO (Catheter, Intravascular, Diagnostic). 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 Map Medical Equipment, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Map Medical Equipment, Inc. since 2007.

Recalls per year

2in 2018

2018: 2
2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • DQOCatheter, Intravascular, Diagnostic1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K952984Map Multitrack Angiographic Catheter (4F)Map Medical Equipment, Inc. · 19961cites it

What has FDA decided for it lately?

  • K952984Map Multitrack Angiographic Catheter (4F)Map Medical Equipment, Inc. · 19962 recalls

The one decision as Map Medical Equipment, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K952984Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage…Oct 17, 2018Class II
  • K952984Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage…Oct 17, 2018Class II