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510(k) K991486

ULTRA-CBX by Medcanica, Inc. — Product Code DWZ

K991486 is an FDA 510(k) premarket notification submitted by Medcanica, Inc. for the device "ULTRA-CBX". The FDA issued a decision of Substantially Equivalent on November 5, 1999. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. Medcanica, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1999
Date Received
April 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biopsy, Endomyocardial
Device Class
Class II
Regulation Number
870.4075
Review Panel
CV
Submission Type

Other clearances by Medcanica, Inc.

  • K011373 — INSTRUMENT DAMPING PORT (October 12, 2001)
  • K011349 — INTERCOSTAL LOCKABLE-DIRECTABLE PORT (October 5, 2001)
  • K994232 — PHALANGEAL FIXATION SYSTEM (March 1, 2000)
  • K991064 — METACARPAL FIXATION SYSTEM (June 23, 1999)

Other clearances for product code DWZ

  • K252722 — Biopsy Forceps (September 30, 2025)
  • K170726 — Biopsy Forceps (June 2, 2017)
  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K010473 — SPARROWHAWK DISPOSABLE (June 6, 2001)
  • K000409 — MODIFICATION TO T-REX BIOPSY FORCEPS (February 28, 2000)
  • K973818 — T-REX BIOPSY FORCEPS (December 16, 1997)
  • K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER (December 16, 1997)
  • K951447 — DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (July 27, 1995)
  • K933235 — CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF (January 6, 1994)
  • K932788 — CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE (September 1, 1993)

FDA data resources