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510(k) K990573

ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA by Estech, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1999
Date Received
February 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

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  • K052081 — REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA (December 16, 2005)
  • K051749 — COBRA SURGICAL SYSTEM (September 13, 2005)
  • K041599 — COBRA ADHERE SURGICAL SYSTEM (July 27, 2004)
  • K032632 — REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH (October 22, 2003)

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