Teleport Glide Microcatheter— 510(k) K253361
Substantially EquivalentOrbusNeich Medical (Shenzhen) Co., Ltd.
FDA 510(k) clearance K253361 for Teleport Glide Microcatheter, Substantially Equivalent on 2026-04-10. Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.. Device class: 2.
Summary
The Teleport Glide Microcatheter is a small-diameter catheter used to support guidewires and deliver devices through tight or distal vessels. It's filed under DQY, percutaneous catheters.
Class II, 21 CFR 870.1250. The Cardiovascular panel reviewed it as a Traditional 510(k).
OrbusNeich Medical filed through its Shenzhen, China, entity. OrbusNeich sells interventional cardiology devices, and Teleport is one of its existing microcatheter lines, so "Glide" is likely a new variant. Review took 192 days (September 30, 2025 to April 10, 2026).
Clearance details
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code DQY
view allMore clearances from OrbusNeich Medical (Shenzhen) Co., Ltd.
view allAdverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.