Atlas FDA

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)

FDA 510(k) clearance K242588 · decided 2025-01-07

Clearance details

K-number
K242588
Device name
COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
Decision
Substantially Equivalent
Date received
2024-08-30
Decision date
2025-01-07
Days to decision
130 days
Clearance type
Traditional
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Shenzhen, CN
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Teleport Glide Microcatheter (K253361)OrbusNeich Medical (Shenzhen) Co., Ltd.2026-04-10
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Scoreflex NC Scoring PTCA Catheter (P200041/S009)OrbusNeich Medical (Shenzhen) Co., Ltd.2025-10-29
Scoreflex NC Scoring PTCA Catheter (P200041/S008)OrbusNeich Medical (Shenzhen) Co., Ltd.2025-05-30
Scoreflex NC Scoring PTCA Catheter (P200041/S007)OrbusNeich Medical (Shenzhen) Co., Ltd.2025-05-29
Scoreflex NC Scoring PTCA Catheter (P200041/S006)OrbusNeich Medical (Shenzhen) Co., Ltd.2025-04-29
Scoreflex NC Scoring PTCA Catheter (P200041/S004)OrbusNeich Medical (Shenzhen) Co., Ltd.2025-04-26
Scoreflex NC Scoring PTCA Catheter (P200041/S003)OrbusNeich Medical (Shenzhen) Co., Ltd.2025-04-25
Scoreflex NC Scoring PTCA Catheter (P200041/S002)OrbusNeich Medical (Shenzhen) Co., Ltd.2024-08-01
Scoreflex NC (P200041/S001)OrbusNeich Medical (Shenzhen) Co., Ltd.2023-06-29