Home / 510(k) Clearances / K897137

510(k) K897137

RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING by Research Medical, Inc. — Product Code DTL

K897137 is an FDA 510(k) premarket notification submitted by Research Medical, Inc. for the device "RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING". The FDA issued a decision of Substantially Equivalent on March 27, 1990. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Research Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1990
Date Received
December 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
Review Panel
CV
Submission Type

Other clearances by Research Medical, Inc.

  • K970739 — RMI HEMOCONCENTRATOR PREFERENCE PACK (July 8, 1997)
  • K964833 — RMI DUAL FLUID IRRIGATING SYRINGE (February 19, 1997)
  • K961927 — RMI HEMOCONCENTRACTOR TUBING SET (August 13, 1996)
  • K960098 — RMI INTERNAL MAMMARY ARTERY CANNULA (March 26, 1996)
  • K951344 — RMI HEMOCONCENTRATOR (August 15, 1995)
  • K922083 — RMI SURGICCAL SITE VISUALIZATION WAND (January 29, 1993)
  • K920936 — RMI EXTERNAL CORONARY ARTERY OCCLUDER (December 18, 1992)
  • K915869 — RMI NORMOCLUDER CORONARY ARTERY OCCLUDER (December 8, 1992)
  • K920676 — RMI SOFCLAMP (April 15, 1992)
  • K910221 — RMI VASCULAR TOURNIQUET KIT (May 16, 1991)

Other clearances for product code DTL

  • K152528 — Attachable Cath Lab Hemostasis Valve (December 2, 2015)
  • K143429 — Passage Hemostasis Valve (December 22, 2014)
  • K140475 — ROTATING ADAPTERS (April 16, 2014)
  • K131124 — COLIGN (August 28, 2013)
  • K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE L (December 13, 2012)
  • K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (October 12, 2012)
  • K122301 — GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (September 7, 2012)
  • K120069 — MEDLINE STOPCOCK AND MANIFOLD (April 3, 2012)
  • K113148 — E-PASS (February 28, 2012)
  • K113845 — TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (January 25, 2012)

FDA data resources