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510(k) K801885

HANCOCK * OBTURATORS by Hancock Laboratories, Inc. — Product Code DTI

K801885 is an FDA 510(k) premarket notification submitted by Hancock Laboratories, Inc. for the device "HANCOCK * OBTURATORS". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code DTI (Sizer, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3945. Hancock Laboratories, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1980
Date Received
August 7, 1980
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 by Hancock Laboratories, Inc.

  • K800703 — MODIFIED CATHETER PACKAGE (April 8, 1980)
  • K800122 — HANCOCK AORTIC PUNCH (February 1, 1980)
  • K790534 — MERSILENE SUTURES (March 26, 1979)
  • K780568 — DURAN FLEXIBLE RING (May 26, 1978)

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)
  • K820887 — MITRAL VALVE ORIFICE SIZER (July 8, 1982)

FDA data resources