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510(k) K872154

MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH by Ideas For Medicine, Inc. — Product Code DQT

K872154 is an FDA 510(k) premarket notification submitted by Ideas For Medicine, Inc. for the device "MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH". The FDA issued a decision of Substantially Equivalent on August 3, 1987. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370. Ideas For Medicine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1987
Date Received
June 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Occluder, Catheter Tip
Device Class
Class II
Regulation Number
870.1370
Review Panel
CV
Submission Type

Other clearances by Ideas For Medicine, Inc.

  • K961883 — VERSA-CATH ARTERIAL CATHETER (January 13, 1997)
  • K962751 — IDEAS' DUAL PORT (September 30, 1996)
  • K961716 — VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE (September 19, 1996)
  • K960715 — PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F (September 9, 1996)
  • K960422 — PRUITT SAFETY OCCLUSION CATHETER (August 7, 1996)
  • K954713 — DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) (July 24, 1996)
  • K935964 — IDEAS OCCLUDER (January 4, 1995)
  • K935023 — GODAT UTERINE MANIPULATOR INJECTOR (January 4, 1995)
  • K880231 — MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (May 25, 1988)
  • K872090 — THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT (October 30, 1987)

Other clearances for product code DQT

  • K983927 — GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT (March 11, 1999)
  • K945963 — THE OMNIGUIDE GUIDING CATHETER WITH BALLOON (February 8, 1995)
  • K910916 — CATHLAB SILICONE OCCLUSION BALLOON CATHETER (June 24, 1991)
  • K910339 — AVD INTIMAX OCCLUSION CATHETER (May 29, 1991)
  • K880860 — CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 (May 26, 1988)
  • K880231 — MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (May 25, 1988)
  • K872090 — THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT (October 30, 1987)
  • K872790 — PERFUSION CATHETER (September 15, 1987)
  • K863559 — URESIL OCCLUSION BALLOON CATHETER (October 10, 1986)
  • K844918 — OCCLUSION & OCCLUSION-IRRIGATION (August 5, 1985)

FDA data resources