TRACHEOSTOMY CARE KIT— 510(k) K921281
UnknownTrinity Laboratories, Inc.
FDA 510(k) clearance K921281 for TRACHEOSTOMY CARE KIT, Unknown on 1992-08-27. Applicant: Trinity Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Trinity Laboratories, Inc.
- Product code
- Code BTO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Salisbury, MD, US
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- K233713 — Pilling Tracheostomy Tubes
- K192511 — Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm
- K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
More clearances from Trinity Laboratories, Inc.
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.