Atlas FDA

PICOCLAMP

FDA 510(k) clearance K230281 · decided 2023-10-23

Clearance details

K-number
K230281
Device name
PICOCLAMP
Applicant
Kono Seisakusho Co., Ltd.
Decision
Substantially Equivalent
Date received
2023-02-01
Decision date
2023-10-23
Days to decision
264 days
Clearance type
Traditional
Product code
DXC
Device class
2
Regulation number
870.4450
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Ichikawa City, JP
Third-party review
No
Expedited review
No

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Similar devices under this product code

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RecordFirmDate
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Radial Compression Device (K232577)Ningbo Dizegens Medical Science Co.,Ltd2024-01-18
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (K221661)Compression Works, Inc.2023-03-03
VIOLA (K230248)Vascular Graft Solutions, Ltd.2023-02-28
Radial Artery Compression Tourniquets (K222182)Beijing Demax Medical Technology Co.,Ltd2023-01-04
GEM Biover Microvascular Clamps (K221843)Synovis Micro Companies Alliance, Inc.2022-09-14
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Recalls involving this device

No recalls on record reference this clearance.