Home / 510(k) Clearances / K820887

510(k) K820887

MITRAL VALVE ORIFICE SIZER by Celtech — Product Code DTI

K820887 is an FDA 510(k) premarket notification submitted by Celtech for the device "MITRAL VALVE ORIFICE SIZER". The FDA issued a decision of Substantially Equivalent on July 8, 1982. The device falls under product code DTI (Sizer, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3945.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1982
Date Received
March 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sizer, Heart-Valve, Prosthesis
Device Class
Class I
Regulation Number
870.3945
Review Panel
CV
Submission Type

Other clearances for product code DTI

  • K952184 — CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (November 29, 1995)
  • K934951 — VALVE SIZER (December 10, 1993)
  • K881279 — EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (May 18, 1988)
  • K853313 — DUROMEDICS CARDIAC VALVE SIZER SET (November 1, 1985)
  • K852612 — METRONIC MODEL F7700 HEART VALVE SIZERS (September 23, 1985)
  • K801885 — HANCOCK * OBTURATORS (September 9, 1980)

FDA data resources