SUCTION CATHETER KIT— 510(k) K863497

Name: FDA 510(k) clearance K863497
Creator: U.S. Food and Drug Administration
Published: 1986-10-06

Substantially Equivalent

Welmed Systems, Inc.

FDA 510(k) clearance K863497 for SUCTION CATHETER KIT, Substantially Equivalent on 1986-10-06. Applicant: Welmed Systems, Inc.. Device class: 1.

Clearance details

Applicant: Welmed Systems, Inc.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1986-09-09
Decision date: 1986-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Swanzey, NH, US

Download summary PDF View on FDA.gov ↗

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K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29

More clearances from Welmed Systems, Inc.

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K863281 — CARE + PLUS IRREGATION TRAY1986-10-31
K863282 — CARE + PLUS CATHETER CARE TRAY1986-10-31
K863284 — I.V. START KIT1986-09-22
K863283 — CARE + PLUS SUTURE REMOVAL TRAY1986-09-15
K862663 — TRACHEOSTOMY CARE TRAY1986-07-30

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.