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510(k) K131124

COLIGN by Jilin Coronado Medical , Ltd. — Product Code DTL

K131124 is an FDA 510(k) premarket notification submitted by Jilin Coronado Medical , Ltd. for the device "COLIGN". The FDA issued a decision of Substantially Equivalent on August 28, 2013. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Jilin Coronado Medical , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2013
Date Received
April 22, 2013
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 Jilin Coronado Medical , Ltd.

  • K131411 — COSEAL (September 26, 2013)

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)
  • 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)
  • K113132 — DISPOSABLE HEMOSTATIC Y-CONNECTORS (January 20, 2012)

FDA data resources