Atlas FDA

TRAcelet Compression Device

FDA 510(k) clearance K162027 · decided 2016-10-21

Clearance details

K-number
K162027
Device name
TRAcelet Compression Device
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2016-07-22
Decision date
2016-10-21
Days to decision
91 days
Clearance type
Traditional
Product code
DXC
Device class
2
Regulation number
870.4450
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Danvers, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
PreludeSYNC™ Radial Compression Device (K262086)Merit Medical Systems, Inc.2026-07-22
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (K260105)Edwards Lifesciences2026-06-05
Arc Adjustable Radial Cuff Compression Device (K252772)Tz Medical, Inc.2026-05-22
Life Saving Tourniquet (K254060)TW Medical2026-04-03
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) (K243627)Arc Trauma, LLC2025-12-31
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (K253070)Medline Industries, LP2025-11-20
Radial Compression Device (K232577)Ningbo Dizegens Medical Science Co.,Ltd2024-01-18
PICOCLAMP (K230281)Kono Seisakusho Co., Ltd.2023-10-23
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089)Medtronic Vascular2025-12-19
Endurant II/IIs Stent Graft System (P100021/S131)Medtronic Vascular2025-10-23
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129)Medtronic Vascular2025-09-15
Resolute Onyx (P160043/S088)Medtronic Vascular2025-06-26
Endurant Stent Graft System (P100021/S130)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072)Medtronic Vascular2025-05-20
Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069)Medtronic Vascular2025-05-08