510(k) K063245
K063245 is an FDA 510(k) premarket notification submitted by Bacterin International, Inc. for the device "ELUTIA COATED CLOSED SURGICAL WOUND DRAIN". The FDA issued a decision of Substantially Equivalent on November 28, 2007. The device falls under product code OEI (Drainage Catheter With Antibiotic), a Class II device regulated under 21 CFR 878.4780. Bacterin International, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 2007
- Date Received
- October 26, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drainage Catheter With Antibiotic
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type
A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.