SCOOP 1— 510(k) K981080
Substantially EquivalentTranstracheal Systems
FDA 510(k) clearance K981080 for SCOOP 1, Substantially Equivalent on 1998-06-17. Applicant: Transtracheal Systems. Device class: 2.
Clearance details
- Applicant
- Transtracheal Systems
- 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
- Boulder, CO, US
Recent devices under product code BTO
view all- K253063 — Venti-Trach Tracheostomy Tube (4 models)
- K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm +3 more
- 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 Transtracheal Systems
view all- K982943 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
- K981078 — TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
- K962944 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
- K904748 — TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
- K904749 — TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.