510(k) K031057
K031057 is an FDA 510(k) premarket notification submitted by Portex, Inc. for the device "PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT". The FDA issued a decision of Substantially Equivalent on July 18, 2003. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Portex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2003
- Date Received
- April 3, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube Tracheostomy And Tube Cuff
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type