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510(k) K990689

ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 by Zcv ,Inc. — Product Code LJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1999
Date Received
March 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Zcv ,Inc.

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  • K003118 — Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 (December 20, 2000)
  • K002481 — ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 (December 7, 2000)
  • K991060 — ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 (April 6, 2000)

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