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510(k) K853749

CUSTOM CORONARY MANIFOLD KITS by Procedure Products, Inc. — Product Code DTL

K853749 is an FDA 510(k) premarket notification submitted by Procedure Products, Inc. for the device "CUSTOM CORONARY MANIFOLD KITS". The FDA issued a decision of Substantially Equivalent on January 13, 1986. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Procedure Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1986
Date Received
September 9, 1985
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 Procedure Products, Inc.

  • K161812 — Freedom Syringe (March 27, 2017)
  • K923194 — INSUFFLATOR CONNECTING FILTER (October 8, 1993)
  • K922536 — TORQUE DEVICE (December 10, 1992)
  • K914128 — CONNECTING SET (November 27, 1991)
  • K910673 — BAG SPIGOT (April 24, 1991)
  • K884985 — MODIFIED 10CC SYRINGE CONTROL RING SET (December 20, 1988)
  • K874747 — 10CC SYRINGE CONTROL RING SET (February 4, 1988)
  • K874037 — ANGIO WASTE FLUIDS DUMP BAG (January 29, 1988)
  • K842173 — DISPOSABLE STOPCOCKS (September 5, 1984)
  • K833554 — MATERIAL ADDITION LEXAN & K-RESIN (March 12, 1984)

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