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510(k) K983769

DISTAFLO BYPASS GRAFT by Impra, Inc. — Product Code DYF

K983769 is an FDA 510(k) premarket notification submitted by Impra, Inc. for the device "DISTAFLO BYPASS GRAFT". The FDA issued a decision of Substantially Equivalent on December 15, 1998. The device falls under product code DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter), a Class II device regulated under 21 CFR 870.3450. Impra, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1998
Date Received
October 26, 1998
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

Other clearances by Impra, Inc.

  • K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (May 14, 2001)
  • K004011 — IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS (March 27, 2001)
  • K991027 — BI-DIRECTIONAL TUNNELER (April 22, 1999)
  • K983861 — DISTAFLO BYPASS GRAFT (November 24, 1998)
  • K983064 — IMPRA HIGH POROSITY GRAFT (November 19, 1998)
  • K981079 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K971192 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (April 15, 1997)
  • K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (March 20, 1997)
  • K964197 — IMPRA CARBOFLO EPTFE VASCULAR GRAFT (January 2, 1997)

Other clearances for product code DYF

  • K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (May 14, 2001)
  • K000504 — ADVANTA SUPER SOFT GRAFT (March 1, 2000)
  • K992958 — ADVANTA GRAFT (<6MM) (October 1, 1999)
  • K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT (September 8, 1999)
  • K992441 — ADVANTA GRAFT (August 20, 1999)
  • K984183 — PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 (February 1, 1999)
  • K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (March 20, 1997)
  • K960766 — MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (March 19, 1997)
  • K955533 — DIASTAT VASCULAR ACCESS GRAFT (May 15, 1996)

FDA data resources