REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)— 510(k) K810321
Substantially EquivalentNational Catheter Co. Div. Mallinckrodt
FDA 510(k) clearance K810321 for REINFORCED TRACHEOSTOMY TUBE SET(TENTAT), Substantially Equivalent on 1981-03-04. Applicant: National Catheter Co. Div. Mallinckrodt. Device class: 2.
Clearance details
- Applicant
- National Catheter Co. Div. Mallinckrodt
- 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
- Walker, MI, US
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More clearances from National Catheter Co. Div. Mallinckrodt
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.