FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Teleport Glide Microcatheter
K Number: K253361
·
Decision Apr 10, 2026
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
9
Review Days
192
Basic Information
- Device Name
- Teleport Glide Microcatheter
- K Number
- K253361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- Date Received
- September 30, 2025
- Decision Date
- April 10, 2026
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by OrbusNeich Medical (Shenzhen) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | Aug 15, 2024 | Substantially Equivalent |
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| K202231 | JADE | Dec 10, 2020 | Substantially Equivalent |
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