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510(k) K971504

HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER by J-Lloyd Medical, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1998
Date Received
April 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by J-Lloyd Medical, Inc.

  • 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)
  • 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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