510(k) Report

FDA applicant

Peripheral Systems Group

Mountain View, CA17 decisions1990–19941 recall

FDA records 17 decisions for Peripheral Systems Group (Mountain View, CA) from 1990 to 1994: 17 510(k) clearances. Most are in product codes LIT (Catheter, Angioplasty, Peripheral, Transluminal) and ITX (Transducer, Ultrasonic, Diagnostic). 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 Peripheral Systems Group’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Peripheral Systems Group 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 — Peripheral Systems Group by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Peripheral”

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