SUCTION CATHETER KIT— 510(k) K861949

Name: FDA 510(k) clearance K861949
Creator: U.S. Food and Drug Administration
Published: 1986-10-22

Substantially Equivalent

Medi-Craft , Ltd.

FDA 510(k) clearance K861949 for SUCTION CATHETER KIT, Substantially Equivalent on 1986-10-22. Applicant: Medi-Craft , Ltd.. Device class: 1.

Clearance details

Applicant: Medi-Craft , Ltd.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1986-05-20
Decision date: 1986-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario L4t 1l2, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSY

view all

K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM2003-11-25
K992902 — AMBU HAND POWER SUCTION PUMP1999-10-25
K982945 — DUAL PURPOSE CLOSED CATHETER1998-09-22
K981910 — SUCTION CATHETER1998-08-24
K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29

More clearances from Medi-Craft , Ltd.

view all

K800505 — URETHRAL CATHETER1980-04-08
K800507 — FEEDING TUBES1980-04-08
K800508 — STOMACH TUBES1980-04-08
K800510 — RECTAL & HARRIS FLUSH TUBES1980-04-08
K800506 — OXYGEN CATHETER1980-03-25

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.