Home / 510(k) Clearances / K032827

510(k) K032827

KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 by Tyco Healthcare — Product Code KSR

K032827 is an FDA 510(k) premarket notification submitted by Tyco Healthcare for the device "KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501". The FDA issued a decision of Substantially Equivalent on December 8, 2003. The device falls under product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components), a Class II device regulated under 21 CFR 864.9100. Tyco Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2003
Date Received
September 10, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class
Class II
Regulation Number
864.9100
Review Panel
HE
Submission Type

Other clearances by Tyco Healthcare

  • K071049 — DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR (October 16, 2007)
  • K070685 — KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 (September 14, 2007)
  • K070653 — KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 (September 12, 2007)
  • K061492 — MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE (August 3, 2006)
  • K042709 — DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER (January 18, 2005)
  • K040897 — DOVER ROB-NEL CATHETER (July 20, 2004)
  • K040649 — KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE (July 15, 2004)
  • K041243 — DOVER RED RUBBER ROBINSON CATHETER (July 7, 2004)
  • K032438 — MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PRE (June 30, 2004)
  • K033453 — KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING (April 29, 2004)

Other clearances for product code KSR

  • K020753 — DEROYAL SURGICAL, UMBILICUP (June 13, 2002)
  • K810897 — ALPHA PLASTIC PLASMA BOTTLE (September 23, 1981)
  • K810500 — BLOOD FREEZING BAG (September 23, 1981)
  • K811523 — PLASMA FLEX (September 9, 1981)
  • K811449 — HAEMONETICS 1000ML COMPONENT BAG (July 1, 1981)
  • K810711 — HAEMONETICS 600 ML. COMPONENT BAG (May 8, 1981)
  • K810313 — HAEMONETICS 1400 ML THERAPEUTIC BAG (March 31, 1981)
  • K801082 — GAMBRO HEMOFREEZE-BAG (October 31, 1980)
  • K801219 — PLASMAPOOLER (October 31, 1980)
  • K792395 — PHARMAFLEX CRYOGENIC BAG (February 26, 1980)

FDA data resources