KENDALL MODU-VAC CLOSED SUCTION SYSTEM— 510(k) K944251

Name: FDA 510(k) clearance K944251
Creator: U.S. Food and Drug Administration
Published: 1994-09-21

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K944251 for KENDALL MODU-VAC CLOSED SUCTION SYSTEM, Substantially Equivalent on 1994-09-21. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: 1.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1994-08-31
Decision date: 1994-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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K982945 — DUAL PURPOSE CLOSED CATHETER1998-09-22
K981910 — SUCTION CATHETER1998-08-24
K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29

More clearances from Kendall Healthcare Products Co. Div.Of Tyco Health

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K973763 — KENDALL CURITY IODOFORM PACKING STRIP1997-12-31
K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04

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.