510(k) K113043
K113043 is an FDA 510(k) premarket notification submitted by Summit Medical Products, Inc. for the device "DIRECT ANTIBIOTIC INFUSION KIT". The FDA issued a decision of Substantially Equivalent on December 20, 2011. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Summit Medical Products, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2011
- Date Received
- October 13, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type