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510(k) K897197

ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. by Advance Medical Designs, Inc. — Product Code DTL

K897197 is an FDA 510(k) premarket notification submitted by Advance Medical Designs, Inc. for the device "ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.". The FDA issued a decision of Substantially Equivalent on March 19, 1990. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Advance Medical Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1990
Date Received
December 29, 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 Advance Medical Designs, Inc.

  • K223689 — Disposable Needle Guides and Grids (August 2, 2023)
  • K163050 — Advance Medical Designs, Inc. Sterile Ultrasound Gel (October 25, 2017)
  • K053495 — EQUIPMENT SLUSH DRAPE (March 16, 2006)
  • K011265 — ULTRASOUND TRANSDUCER COVER (October 30, 2001)
  • K012168 — ADVANCE MEDICAL DESIGNS FLUID POUCH (September 18, 2001)
  • K011422 — SURGICAL DRAPES (July 10, 2001)
  • K003670 — PATIENT DRAPE, SURGICAL (January 26, 2001)
  • K911884 — ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES (July 5, 1994)
  • K925115 — AMD DENTIST AND HYGIENIST KITS (July 5, 1994)
  • K915301 — ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK (December 11, 1992)

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