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510(k) K941214

LIFESHIELD EXTENSION SET by Abbott Mfg., Inc. — Product Code FPK

K941214 is an FDA 510(k) premarket notification submitted by Abbott Mfg., Inc. for the device "LIFESHIELD EXTENSION SET". The FDA issued a decision of Substantially Equivalent on October 3, 1994. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Abbott Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1994
Date Received
March 10, 1994
Clearance Type
Traditional
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 Abbott Mfg., Inc.

  • K981457 — ALBP (May 27, 1998)
  • K981232 — CA (May 18, 1998)
  • K981231 — CO2 (May 12, 1998)
  • K965230 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP (July 3, 1997)
  • K971293 — LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE (June 27, 1997)
  • K953656 — ABBOTT IMX PROLACTIN(MODIFICATION) (October 3, 1995)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (September 25, 1995)
  • K944669 — FLEXIFLO QUANTUM ENTERAL PUMP (July 24, 1995)
  • K943691 — IMX FOLATE (March 23, 1995)
  • K943733 — FLEXIFLO SIX ENTERAL NUTRITION PUMP (December 12, 1994)

Other clearances for product code FPK

  • K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (August 2, 2013)
  • 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)

FDA data resources