510(k) K201794
K201794 is an FDA 510(k) premarket notification submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. for the device "Jade". The FDA issued a decision of Substantially Equivalent on July 28, 2020. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. OrbusNeich Medical (Shenzhen) Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2020
- Date Received
- June 30, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type