510(k) K211078
K211078 is an FDA 510(k) premarket notification submitted by Terumo Clinical Supply Co., Ltd. for the device "Progreat Lambda". The FDA issued a decision of Substantially Equivalent on Dec 21, 2021. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 21, 2021
- Date Received
- Apr 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type