DeviceClearance

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube— 510(k) K173384

Substantially Equivalent

Smiths Medical Ads, Inc.

FDA 510(k) clearance K173384 for BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube, Substantially Equivalent on 2018-04-10. Applicant: Smiths Medical Ads, Inc.. Device class: 2.

Clearance details

Applicant
Smiths Medical Ads, Inc.
Product code
Code BTO
Device class
Class 2
Regulation
21 CFR 868.5800
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

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More clearances from Smiths Medical Ads, Inc.

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Adverse events under product code BTO

product code BTO
Death
14
Injury
328
Malfunction
1,851
Total
2,193

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K173384

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173384.

Data sourced from openFDA. This site is unofficial and independent of the FDA.