510(k) K063048
K063048 is an FDA 510(k) premarket notification submitted by Tran Pa-C, Inc. for the device "TRANS-CATHETER EXTRACTOR". The FDA issued a decision of Substantially Equivalent on September 14, 2007. The device falls under product code ODY (Tunneled Catheter Remover), a Class II device regulated under 21 CFR 880.5970.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2007
- Date Received
- October 4, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tunneled Catheter Remover
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type
To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.