510(k) K211530
K211530 is an FDA 510(k) premarket notification submitted by Shanghai Microport EP Medtech Co., Ltd. for the device "PathBuilder Steerable Introducer". The FDA issued a decision of Substantially Equivalent on February 8, 2022. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Shanghai Microport EP Medtech Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2022
- Date Received
- May 17, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type