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510(k) K900994

ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT. by Dlp, Inc. — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1990
Date Received
March 2, 1990
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 Dlp, Inc.

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  • K953945 — RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTR (March 26, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K934215 — CONTAIN-OR (February 9, 1994)
  • K915268 — CATHETER TWO STAGE VENOUS RETURN (July 27, 1992)
  • K914608 — BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 (January 9, 1992)
  • K913077 — LANCASTER COOLING JACKET, CAT. CODE #13500/13501 (January 9, 1992)
  • K913098 — APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 (November 5, 1991)
  • K912229 — IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 (September 25, 1991)

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  • 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)