Home / 510(k) Clearances / K082923

510(k) K082923

PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C by Life-Tech, Inc. — Product Code CAC

K082923 is an FDA 510(k) premarket notification submitted by Life-Tech, Inc. for the device "PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C". The FDA issued a decision of Substantially Equivalent on October 24, 2008. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Life-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2008
Date Received
October 1, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type

Other clearances by Life-Tech, Inc.

  • K120234 — EZONO 3000 (April 19, 2012)
  • K111355 — ECHOBRIGHT (September 16, 2011)
  • K102813 — EZONO 3000 (June 30, 2011)
  • K102007 — PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, (December 22, 2010)
  • K093662 — ECHOBRIGHT (June 24, 2010)
  • K093485 — VESISCAN (March 16, 2010)
  • K082772 — STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC191 (February 9, 2009)
  • K082056 — ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 (November 7, 2008)
  • K081864 — PROLONG (September 25, 2008)
  • K073187 — PERIPHERAL NERVE BLOCK SUPPORT TRAY (April 22, 2008)

Other clearances for product code CAC

  • K241236 — XTRA Collection sets; XTRA Sequestration set X (August 16, 2024)
  • K240426 — Aventus Clot Management System (May 14, 2024)
  • K240584 — XTRA Autotransfusion System (with XTRA Bowl sets) (April 29, 2024)
  • K231782 — FlowSaver Blood Return System (80-101) (July 14, 2023)
  • K221483 — FlowSaver Blood Return System (February 17, 2023)
  • K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (November 15, 2022)
  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)

FDA data resources