K253361

Substantially Equivalent

Teleport Glide Microcatheter

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.

Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
Product code: DQY
Advisory panel: Cardiovascular
Date received: 2025-09-30
Decision date: 2026-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.