FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BIOTEQ Drainage Catheter BT-PDS-series
K Number: K210419
·
Decision Apr 13, 2022
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
3
Review Days
426
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Basic Information
- Device Name
- BIOTEQ Drainage Catheter BT-PDS-series
- K Number
- K210419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioteque Corporation
- Date Received
- February 11, 2021
- Decision Date
- April 13, 2022
- Product Code
- FGE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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