510(k) K071382
SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, by
Shinchang Medical Co., Ltd.
— Product Code FOZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2007
- Date Received
- May 17, 2007
- 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