Teleport Glide Microcatheter
FDA 510(k) K253361 · OrbusNeich Medical (Shenzhen) Co., Ltd.
510(k) numberK253361
Submission
- Device name
- Teleport Glide Microcatheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
Shenzhen, CN - Received
- September 30, 2025
- Decision date
- April 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
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| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)DQY · Traditional | 01/07/2025SE |
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| K233505 | Sapphire ULTRA Coronary Dilatation CatheterLOX · Traditional | 08/15/2024SE |
| K241025 | JADE PLUS PTA Balloon Dilatation CatheterLIT · Traditional | 06/11/2024SE |
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| K211807 | Sapphire NC 24LOX · Traditional | 10/14/2021SE |
| K202231 | JadeLIT · Traditional | 12/10/2020SE |
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Questions and answers
When was Teleport Glide Microcatheter cleared by the FDA?
Teleport Glide Microcatheter (K253361) received a 510(k) decision of Substantially Equivalent on April 10, 2026, 192 days after the submission was received.
What is the product code of K253361?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.