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..
Summary
The Teleport Glide Microcatheter is a small-diameter intravascular catheter for guiding devices into peripheral or coronary vasculature. Product code DQY covers intravascular catheters broadly; "microcatheter" implies sub-millimeter outer diameters used for distal access in neurovascular and interventional cardiology procedures.
Cardiovascular panel, Traditional 510(k). OrbusNeich is a well-established interventional cardiology company with a long 510(k) history; this reads as an addition to their existing catheter portfolio rather than a new platform.
OrbusNeich Medical files from Shenzhen. Roughly six-month review clock — typical for a well-characterized predicate comparison on DQY.
Clearance details
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- Product code
- Code DQY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse 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.