Home / 510(k) Clearances / K935405

510(k) K935405

ARTERIAL EMBOLECTOMY by J-Lloyd Medical, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1994
Date Received
November 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by J-Lloyd Medical, Inc.

  • K971504 — HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER (April 20, 1998)
  • K973639 — ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. (April 20, 1998)
  • K974336 — CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. (February 13, 1998)
  • K974335 — EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. (February 13, 1998)
  • K963248 — FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) (February 3, 1997)
  • K950440 — DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD (September 15, 1995)
  • K940547 — FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED (August 11, 1994)
  • K935403 — WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD (May 12, 1994)
  • K935404 — FLOW DIRECTED THERMODILUTION BALLOON CATHETER (May 3, 1994)
  • K935402 — ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD (April 26, 1994)

Other clearances for product code DXE

  • K240078 — Fogarty Thru-Lumen Embolectomy Catheter (August 28, 2024)
  • K241330 — Fogarty Fortis Arterial Embolectomy Catheter (July 2, 2024)
  • K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve (May 22, 2024)
  • K233819 — Fogarty Venous Thrombectomy Catheters (May 22, 2024)
  • K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (May 20, 2024)
  • K213771 — Merlin Aspiration System (January 27, 2022)
  • K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (September 7, 2021)
  • K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (June 12, 2020)
  • K163031 — Bunegin-Albin Air Aspiration Set (July 27, 2017)
  • K163353 — Needle's Eye Snare Retrieval Set - 54cm (July 11, 2017)