510(k) K130405
K130405 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET". The FDA issued a decision of Substantially Equivalent on November 6, 2013. The device falls under product code BWC (Needle, Emergency Airway), a Class II device regulated under 21 CFR 868.5090. Teleflex Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2013
- Date Received
- February 19, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Emergency Airway
- Device Class
- Class II
- Regulation Number
- 868.5090
- Review Panel
- AN
- Submission Type