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510(k) K180757

D-Clip; D-Clip Applier by Peter Lazic GmbH — Product Code HCH

K180757 is an FDA 510(k) premarket notification submitted by Peter Lazic GmbH for the device "D-Clip; D-Clip Applier". The FDA issued a decision of Substantially Equivalent on April 12, 2019. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Peter Lazic GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2019
Date Received
March 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Aneurysm
Device Class
Class II
Regulation Number
882.5200
Review Panel
NE
Submission Type

Other clearances by Peter Lazic GmbH

  • K081489 — L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YAS (September 25, 2008)

Other clearances for product code HCH

  • K211183 — Sugita AVM Microclips (March 2, 2022)
  • K131500 — YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS (January 24, 2014)
  • K091921 — CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REI (September 8, 2009)
  • K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (May 6, 2009)
  • K081489 — L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YAS (September 25, 2008)
  • K060915 — KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APP (April 17, 2007)
  • K043041 — AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) (December 9, 2004)
  • K032198 — AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP (August 20, 2003)
  • K031468 — TEMPORARY TITANIUM ANEURYSM CLIP (June 20, 2003)
  • K024349 — AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER (March 24, 2003)

FDA data resources