510(k) K861645
K861645 is an FDA 510(k) premarket notification submitted by Aci Medical, Inc. for the device "MICRO-TRACHEOSTOMY CARE KIT". The FDA issued a decision of Substantially Equivalent on May 9, 1986. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Aci Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1986
- Date Received
- April 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheostomy (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type