510(k) K053120
K053120 is an FDA 510(k) premarket notification submitted by Excelsior Medical Corp. for the device "STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES". The FDA issued a decision of Substantially Equivalent on December 9, 2005. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Excelsior Medical Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2005
- Date Received
- November 7, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type