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510(k) K890453

REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES by Dlp, Inc. — Product Code DWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1989
Date Received
January 30, 1989
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 Dlp, Inc.

  • K973485 — CLEARVIEW BLOWER/MISTER (December 8, 1997)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K953945 — RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTR (March 26, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K934215 — CONTAIN-OR (February 9, 1994)
  • K915268 — CATHETER TWO STAGE VENOUS RETURN (July 27, 1992)
  • K914608 — BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 (January 9, 1992)
  • K913077 — LANCASTER COOLING JACKET, CAT. CODE #13500/13501 (January 9, 1992)
  • K913098 — APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 (November 5, 1991)
  • K912229 — IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 (September 25, 1991)

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)
  • 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)