SOFTOUCH GUIDING CATHETER— 510(k) K902953

Clearance details

Applicant

Mallinckrodt Medical

Product code

Code DQO

Device class

Class 2

Regulation

21 CFR 870.1200

Advisory panel

Cardiovascular

Date received

1990-07-05

Decision date

1990-09-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St Louis, MO, US

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• K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter2025-01-31

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• K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29
• K971267 — SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF1997-09-25
• K963732 — PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA1997-06-26

Death

35

Injury

993

Malfunction

1,772

Other

5

Total

2,805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →