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510(k) K131517

MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING by Medrad, Inc. / Bayer Medical Care, Inc. — Product Code FPK

K131517 is an FDA 510(k) premarket notification submitted by Medrad, Inc. / Bayer Medical Care, Inc. for the device "MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING". The FDA issued a decision of Substantially Equivalent on August 2, 2013. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Medrad, Inc. / Bayer Medical Care, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2013
Date Received
May 28, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Fluid Delivery
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Medrad, Inc. / Bayer Medical Care, Inc.

  • K132928 — MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE (January 23, 2014)

Other clearances for product code FPK

  • K063114 — DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (February 9, 2007)
  • K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, (December 11, 2006)
  • K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801 (November 29, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET (July 11, 2003)
  • K022431 — MEDRAD TRANSFER SET (September 5, 2002)
  • K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128 (February 26, 1997)
  • K953864 — SILCLEAR TUBING (MODIFICATION) (November 6, 1995)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)
  • K952243 — EXTENSION SET/I.V. SET (July 26, 1995)

FDA data resources