CATH-GUIDE— 510(k) K955645

Name: FDA 510(k) clearance K955645
Creator: U.S. Food and Drug Administration
Published: 1996-03-12

Substantially Equivalent

Hudson Respiratory Care, Inc.

FDA 510(k) clearance K955645 for CATH-GUIDE, Substantially Equivalent on 1996-03-12. Applicant: Hudson Respiratory Care, Inc.. Device class: 1.

Clearance details

Applicant: Hudson Respiratory Care, Inc.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1995-12-12
Decision date: 1996-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mccordsville, IN, US

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 Hudson Respiratory Care, Inc.

view all

K031383 — MODEL 7802003-07-07
K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI2001-06-13
K011134 — OXYGEN SUPPLY TUBING, MODEL 11152001-06-13
K010402 — SMOOTH-FLO CIRCUIT2001-03-14
K001213 — CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -602000-11-03

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.