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510(k) K920871

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

K920871 is an FDA 510(k) premarket notification submitted by J-Lloyd Medical, Inc. for the device "J-LLOYD ARTERIAL EMBOLECTOMY CATHETER". The FDA issued a decision of Substantially Equivalent on February 26, 1993. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. J-Lloyd Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1993
Date Received
February 25, 1992
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)
  • K974335 — EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. (February 13, 1998)
  • K974336 — CHOLANGIOGRAPH 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)
  • K935405 — ARTERIAL EMBOLECTOMY (July 25, 1994)
  • K935403 — WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD (May 12, 1994)
  • K935404 — FLOW DIRECTED THERMODILUTION BALLOON CATHETER (May 3, 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)
  • K233819 — Fogarty Venous Thrombectomy Catheters (May 22, 2024)
  • K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve (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)

FDA data resources