FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
PathBuilder Transseptal Guiding Introducer
K Number: K212626
·
Decision Mar 23, 2022
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
4
Review Days
217
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Basic Information
- Device Name
- PathBuilder Transseptal Guiding Introducer
- K Number
- K212626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai Microport EP Medtech Co., Ltd.
- Date Received
- August 18, 2021
- Decision Date
- March 23, 2022
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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