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510(k) K900207

EPICARDIA 4000 by Medicomp, Inc. — Product Code DST

K900207 is an FDA 510(k) premarket notification submitted by Medicomp, Inc. for the device "EPICARDIA 4000". The FDA issued a decision of Substantially Equivalent on July 31, 1990. The device falls under product code DST (Clip, Vena-Cava), a Class II device regulated under 21 CFR 870.3260. Medicomp, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1990
Date Received
January 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Vena-Cava
Device Class
Class II
Regulation Number
870.3260
Review Panel
CV
Submission Type

Other clearances by Medicomp, Inc.

  • K173170 — Epicardia Anywhere (January 10, 2018)
  • K161916 — TelePatch Cardiac Monitor (December 21, 2016)
  • K091696 — SAVI WIRELESS, MODEL PM500 (October 26, 2009)
  • K090834 — EPICARDIA 5000 (May 15, 2009)
  • K043454 — CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 (March 24, 2005)
  • K981119 — CARDIOPAL MODEL NUMBER PM20 (October 14, 1998)
  • K952846 — EPICARDIA (September 18, 1995)
  • K943915 — HEAT AND MOISTURE EXCHANGER FILTER (HME) (October 14, 1994)
  • K883103 — EPICARDIA PC/FC (September 22, 1988)
  • K881770 — EPICARDIA LE/FD (May 31, 1988)

FDA data resources