Name: FDA 510(k) clearance K842558
Creator: U.S. Food and Drug Administration
Published: 1984-07-11

Clearance details

Applicant: Sheridan Catheter Corp.
Product code: Code BTR
Device class: Class 2
Regulation: 21 CFR 868.5730
Advisory panel: Anesthesiology
Date received: 1984-07-02
Decision date: 1984-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Recent devices under product code BTR

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K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)2025-10-06
K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced2025-09-25
K243579 — AeroJet Ventilation Catheter2025-08-13

More clearances from Sheridan Catheter Corp.

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K922894 — LAZER-TRACH TRACHEAL TUBE1993-05-07
K897046 — LASER RESISTANT TRACHEAL TUBE1990-03-23
K890823 — ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER1989-05-05
K884765 — CLINICAL ELECTRONIC THERMOMETERS1989-02-16
K882918 — KIM NASO-INTESTINAL TUBE1988-12-05

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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 →