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510(k) K922787

ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION by Echocath, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1993
Date Received
June 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Echocath, Inc.

  • K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (March 20, 2001)
  • K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER (September 16, 1999)
  • K932436 — ECHOMARK INTRAUTERINE GUIDING CATHETER (November 16, 1995)
  • K933417 — ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER (May 4, 1995)
  • K926351 — COLORMARK(TM) VISUALIZATION SYSTEM (September 16, 1993)

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