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510(k) K991959

PSI TITANIUM ANEURYSM CLIP by V. Mueller Neuro/Spine — Product Code HCH

K991959 is an FDA 510(k) premarket notification submitted by V. Mueller Neuro/Spine for the device "PSI TITANIUM ANEURYSM CLIP". The FDA issued a decision of Substantially Equivalent on January 6, 2000. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. V. Mueller Neuro/Spine has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2000
Date Received
June 10, 1999
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 V. Mueller Neuro/Spine

  • K002276 — PSI SKULL CLAMP (August 29, 2000)
  • K993019 — PACIFIC SURGICAL PATTIES (March 30, 2000)
  • K991002 — PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP (June 11, 1999)
  • K972750 — TAKA ANEURYSM CLIP (July 9, 1998)
  • K964402 — VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM (January 23, 1997)
  • K942601 — PSI FLEXIBLE ARM (December 27, 1994)
  • K943635 — ULTRA-LINE RONGEUR (December 7, 1994)

Other clearances for product code HCH

  • K211183 — Sugita AVM Microclips (March 2, 2022)
  • K180757 — D-Clip; D-Clip Applier (April 12, 2019)
  • 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)

FDA data resources