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510(k) K010473

SPARROWHAWK DISPOSABLE by Atc Technologies, Inc. — Product Code DWZ

K010473 is an FDA 510(k) premarket notification submitted by Atc Technologies, Inc. for the device "SPARROWHAWK DISPOSABLE". The FDA issued a decision of Substantially Equivalent on June 6, 2001. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. Atc Technologies, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
February 20, 2001
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 Atc Technologies, Inc.

  • K121343 — MODULAP LOOP (June 14, 2013)
  • K994319 — MODULAP (March 20, 2000)
  • K983623 — MODULAP (December 18, 1998)

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)
  • K000409 — MODIFICATION TO T-REX BIOPSY FORCEPS (February 28, 2000)
  • K991486 — ULTRA-CBX (November 5, 1999)
  • K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER (December 16, 1997)
  • K973818 — T-REX BIOPSY FORCEPS (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