PathBuilder Transseptal Needle
FDA 510(k) clearance K212625 · decided 2022-03-23
Clearance details
- K-number
- K212625
- Device name
- PathBuilder Transseptal Needle
- Applicant
- Shanghai Microport EP Medtech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-18
- Decision date
- 2022-03-23
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- DRC
- Device class
- 2
- Regulation number
- 870.1390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.