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510(k) K990689

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

K990689 is an FDA 510(k) premarket notification submitted by Zcv ,Inc. for the device "ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9". The FDA issued a decision of Substantially Equivalent on September 3, 1999. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Zcv ,Inc. has at least 5 other 510(k) clearances on record.

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.

  • K010099 — ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER (February 1, 2001)
  • K002603 — ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER (January 8, 2001)
  • 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)

Other clearances for product code LJE

  • K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit (July 3, 2025)
  • K222705 — Introducer Needle (May 22, 2023)
  • K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kit (March 10, 2022)
  • K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (December 17, 2020)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (July 16, 2019)
  • K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Tro (May 17, 2019)
  • K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (March 27, 2019)
  • K181713 — Ultraxx Nephrostomy Balloon Catheter Set (August 17, 2018)

FDA data resources