4 SURE TM NASAL OXYGEN CANNULA— 510(k) K922397

Name: FDA 510(k) clearance K922397
Creator: U.S. Food and Drug Administration
Published: 1993-03-18

Substantially Equivalent

Boston Pacific Medical, Inc.

FDA 510(k) clearance K922397 for 4 SURE TM NASAL OXYGEN CANNULA, Substantially Equivalent on 1993-03-18. Applicant: Boston Pacific Medical, Inc.. Device class: 1.

Clearance details

Applicant: Boston Pacific Medical, Inc.
Product code: Code CAT
Device class: Class 1
Regulation: 21 CFR 868.5340
Advisory panel: Anesthesiology
Date received: 1992-05-21
Decision date: 1993-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI2001-06-13
K935533 — NASAL CANNULA1994-02-03
K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED1992-08-14
K920573 — CANNULA NASAL OXYGEN1992-08-11
K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 815891991-10-18

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K933109 — 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS1994-03-28
K922402 — 4 SURE TM ENTERAL FEEDING BAG1994-03-25
K931047 — 4-SURE FEMALE CATHETER1994-02-14
K931048 — 4-SURE NELATON CATHETER1994-02-14
K921852 — 4 SURE TM RECTAL TUBE1993-10-08

Adverse events under product code CAT

product code CAT

Death: 5
Malfunction: 544
Other: 2
Total: 551

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.