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510(k) K900994

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

K900994 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.". The FDA issued a decision of Substantially Equivalent on August 15, 1990. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Dlp, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K973485 — CLEARVIEW BLOWER/MISTER (December 8, 1997)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • 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)

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