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510(k) K180757

Device
D-Clip; D-Clip Applier
Applicant
Peter Lazic GmbH
510(k) number
K180757
Product code
HCH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-12
Date received
2018-03-22
Regulation
882.5200
Classification name
Clip, Aneurysm
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sven Lazic
Address
Immelmannweg 2 Tuttlingen DE 78532 78532

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HCH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211183Sugita AVM MicroclipsMizuho America, Inc.2022-03-02
K131500YASARGIL ANEURYSM CLIPS AND CLIP APPLIERSAesculap, Inc.2014-01-24
K091921CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIPCodman & Shurtleff, Inc.2009-09-08
K081640GIMMI ANEURYSM CLIPS AND APPLYING FORCEPSGimmi GmbH2009-05-06
K081489L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERSPeter Lazic GmbH2008-09-25
K060915KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERSKirwan Surgical Products, Inc.2007-04-17
K043041AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)Aesculap, Inc.2004-12-09
K032198AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIPAesculap, Inc.2003-08-20
K031468TEMPORARY TITANIUM ANEURYSM CLIPCardinalhealth2003-06-20
K024349AESULAP KOPITNIK AVM MICROCLIPS AND APPLIERAesculap, Inc.2003-03-24
K013136ANEURYSM CLIPSGistlstrasse2001-11-26
K010908MEDICON TITANIUM YASARGIL ANEURYSM CLIPSMedicon EG2001-08-01
K003500REBSTOCK YASARGIL ANEURYSM CLIPRebstock - Instrumente GmbH2001-05-30
K003519YASARGIL PERMANENT ANEURYSM CLIPSAesculap, Inc.2001-01-29
K002871MODIFICATION TO YASARGIL ANEURYSM CLIPSAesculap, Inc.2000-10-13