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510(k) K072050

PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS by Life-Tech, Inc. — Product Code BSO

K072050 is an FDA 510(k) premarket notification submitted by Life-Tech, Inc. for the device "PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS". The FDA issued a decision of Substantially Equivalent on October 18, 2007. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Life-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2007
Date Received
July 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
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)
  • K082923 — PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, (October 24, 2008)
  • K081864 — PROLONG (September 25, 2008)

Other clearances for product code BSO

  • K241410 — EDEN ControlCath (February 13, 2025)
  • K231242 — Perifix FX Catheter; Contiplex FX Catheter (September 15, 2023)
  • K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Nex (August 30, 2023)
  • K193664 — SubQKath Catheter and Needle Set (September 9, 2020)
  • K200624 — Percutaneous Introducer (April 27, 2020)
  • K191470 — C-CAT Anaesthesia Catheter kit (October 25, 2019)
  • K181782 — Medline Reinforced Epidural Catheter (March 4, 2019)
  • K173541 — EPINAUT (August 24, 2018)
  • K172777 — Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (May 3, 2018)
  • K171584 — B. Braun Tear-Away Introducer Needle (December 22, 2017)

FDA data resources