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510(k) K974335

EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. by J-Lloyd Medical, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1998
Date Received
November 18, 1997
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)
  • 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)
  • K935402 — ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD (April 26, 1994)

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