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510(k) K891588

TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE) by Ideal Medical, Inc. — Product Code LQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
March 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Ideal Medical, Inc.

  • K944067 — PEANUT WAND, MODIFICATION (December 8, 1994)
  • K931115 — HATCHER STONE-EMBOLIS EXTRACTOR (August 20, 1993)
  • K926335 — IDEAS PEANUT WAND (June 24, 1993)
  • K922161 — GRICE SOFT TISSUE BIOPSY KIT (October 13, 1992)
  • K921922 — GRICE LAPAROSCOPIC SUTURING NEEDLE (July 8, 1992)
  • K915175 — REDDICK RETRACTOR (April 29, 1992)
  • K914880 — DUAL BALLOON EMBOLECTOMY CATHETER (March 16, 1992)
  • K913602 — IDEAS' PORT (January 2, 1992)
  • K914913 — GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST (December 31, 1991)
  • K912540 — CONTOUR-PORT (August 23, 1991)

Other clearances for product code LQR

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  • K240192 — Single-use Extraction Baskets (October 15, 2024)
  • K230598 — Stone Extraction Baskets (September 12, 2023)
  • K203322 — SpyGlass Discover Retrieval Basket (May 26, 2021)
  • K201509 — Disposable Stone Extraction basket (December 16, 2020)
  • K191789 — Stonetome Stone Removal Device (July 25, 2019)
  • K182381 — Wilson-Cook Mini Basket (October 30, 2018)
  • K171969 — Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Mem (March 28, 2018)
  • K171915 — Nathanson Transcystic Bile Duct Stone Exploration Pack (March 1, 2018)