510(k) K024007
K024007 is an FDA 510(k) premarket notification submitted by Sunder Biomedical Tech. Co., Ltd. for the device "SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J". The FDA issued a decision of Substantially Equivalent on Jul 14, 2003. 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. Sunder Biomedical Tech. Co., Ltd. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 14, 2003
- Date Received
- Dec 4, 2002
- Clearance Type
- Traditional
- 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
- 510(k)