SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT— 510(k) K874450
Substantially EquivalentSurgitech C/O Collier, Shannon, Rill & Scott
FDA 510(k) clearance K874450 for SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT, Substantially Equivalent on 1988-02-29. Applicant: Surgitech C/O Collier, Shannon, Rill & Scott. Device class: 2.
Clearance details
- Applicant
- Surgitech C/O Collier, Shannon, Rill & Scott
- 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
- Washington, DC, US
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- K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
More clearances from Surgitech C/O Collier, Shannon, Rill & Scott
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.