MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER— 510(k) K010016
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K010016 for MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER, Substantially Equivalent on 2001-10-09. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- Product code
- Code BWC
- Device class
- Class 2
- Regulation
- 21 CFR 868.5090
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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Recalls naming K010016
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010016.
Data sourced from openFDA. This site is unofficial and independent of the FDA.