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510(k) K951447

DYNABITE CARDIOVASCULAR BIOPSY FORCEPS by Portlyn Corp. — Product Code DWZ

K951447 is an FDA 510(k) premarket notification submitted by Portlyn Corp. for the device "DYNABITE CARDIOVASCULAR BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on July 27, 1995. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. Portlyn Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1995
Date Received
March 29, 1995
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 Portlyn Corp.

  • K970083 — DYNABITE HOT GI BIOPSY FORCEPS (June 17, 1997)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K944245 — DYNABITE LAPAROSCOPIC FORCEPS (November 15, 1994)
  • K934506 — DYNABITE HYSTEROSCOPIC FORCEPS (March 22, 1994)
  • K901300 — BIOPSY FORCEPS (June 29, 1990)
  • K896147 — BIOPSY FORCEP (NON-ELECTRIC) (April 16, 1990)
  • K896146 — BIOPSY FORCEPS, (NON-RIGID) (March 9, 1990)

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)
  • 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