Home / 510(k) Clearances / K201165

510(k) K201165

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath by Coloplast Corp. — Product Code LJE

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 17, 2020
Date Received
May 1, 2020
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 Coloplast Corp.

  • K252140 — Heylo™ System (October 6, 2025)
  • K251116 — Luja Coudé (June 27, 2025)
  • K250270 — Luja Set (April 17, 2025)
  • K242049 — SureCath Set (November 26, 2024)
  • K241210 — Luja Coude (November 21, 2024)
  • K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, (November 12, 2024)
  • K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (5 (October 18, 2024)
  • K241028 — Luja female (20051); Luja female (20052); Luja female (20054); Luja female (2005 (July 26, 2024)
  • K233411 — Folysil Silicone Catheter (April 15, 2024)
  • K231953 — Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - (March 22, 2024)

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)
  • 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)
  • K171601 — Ultraxx Nephrostomy Balloon Catheter (February 23, 2018)