FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
K Number: K013241
·
Decision Feb 21, 2002
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
190
Review Days
146
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Basic Information
- Device Name
- ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
- K Number
- K013241
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5090
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook, Inc.
- Date Received
- September 28, 2001
- Decision Date
- February 21, 2002
- Product Code
- BWC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BWC | Needle, Emergency Airway | FDA class 2 | Anesthesiology |
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