Teleport XT Microcatheter
FDA 510(k) K231608 · OrbusNeich Medical (Shenzhen) Co., Ltd.
510(k) numberK231608
Submission
- Device name
- Teleport XT Microcatheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
Shenzhen, CN - Received
- June 2, 2023
- Decision date
- January 7, 2024
- 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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Questions and answers
When was Teleport XT Microcatheter cleared by the FDA?
Teleport XT Microcatheter (K231608) received a 510(k) decision of Substantially Equivalent on January 7, 2024, 219 days after the submission was received.
What is the product code of K231608?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.