Clip, Vascular

FDA product code DSS · Class II (moderate risk) · 21 CFR 870.3250 · Cardiovascular

8510(k) clearances
0PMA approvals
4recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K983744Mcas (Modular Clip Applier System)DSS · Traditional Applied Medical Resources01/21/1999SE
K961333Heartport Multifire Clip ApplierDSS · Traditional Heartport, Inc.11/15/1996SE
K920104Identi Loops Degania SiliconeDSS · Traditional Puritas Health Care, Inc.04/20/1992SE
K920676Rmi SofclampDSS · Traditional Research Medical, Inc.04/15/1992SE
K914523Cri Vessel Occlusin System/Cri Occlusion CoilDSS · Traditional Catheter Research C/O Burditt, Bowles & Radzius01/10/1992SE
K901303Horizon Surgical Ligating and Marking ClipDSS · Traditional Horizon Surgical, Inc.06/05/1990SE
K883909Surgical Spring ClipsDSS · Traditional Applied Vascular Devices, Inc.12/27/1988SE
K771021Auto-ClipDSS · Traditional Axiom Medical, Inc.06/14/1977SE

Recalls

RecallProductFirmInitiated
Z-2037-2020 Class IISTEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile…Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Applied Medical Resources Corp01/31/2020Terminated
Z-2036-2020 Class IISTEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product…Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Applied Medical Resources Corp01/31/2020Terminated
Z-2035-2020 Class IISTEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product…Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Applied Medical Resources Corp01/31/2020Terminated
Z-2034-2020 Class IISTEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product…Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Applied Medical Resources Corp01/31/2020Terminated