CENTRAL VENOUS CATHETER DRESSING TRAY— 510(k) K791887

Name: FDA 510(k) clearance K791887
Creator: U.S. Food and Drug Administration
Published: 1979-10-17

Substantially Equivalent

Ascep, Inc.

FDA 510(k) clearance K791887 for CENTRAL VENOUS CATHETER DRESSING TRAY, Substantially Equivalent on 1979-10-17. Applicant: Ascep, Inc.. Device class: 1.

Clearance details

Applicant: Ascep, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1979-09-11
Decision date: 1979-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSM

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K971217 — INSTRUMENT TRAY LINER1997-05-06
K962328 — SINGLE USE INSTRUMENT TRAY1996-08-09
K944025 — SURGICAL INSTRUMENT TRAY1994-11-22
K912106 — ARTHROSCOPY TRAY1991-08-29
K912053 — OPEN HEART TRAY1991-08-26

More clearances from Ascep, Inc.

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K830219 — VARIOUS INSTRUMENTS & INSTRUMENT TRAYS1983-04-12
K822893 — G.E.V. DISPOSABLE SCALPELS1982-10-22
K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS1981-01-26
K802726 — INSTRUMENTS NONSTERILE & STERILE1980-11-19
K791886 — I.V. CARE KIT1979-10-26

Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.