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510(k) K951524

THORACENTESIS CATHETER by Baxter Healthcare Corp — Product Code JOL

K951524 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "THORACENTESIS CATHETER". The FDA issued a decision of Substantially Equivalent on Jul 6, 1995. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 6, 1995
Date Received
Apr 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tip, Suction
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (Oct 29, 2015)
  • K130531 — ULTRAFUSE (Apr 8, 2014)
  • K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION (Oct 8, 2013)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (Mar 1, 2013)
  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (Jan 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (Jan 8, 2013)

Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (Aug 12, 2005)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (Jul 12, 2001)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (Jul 12, 2001)
  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (Oct 25, 2000)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (Mar 9, 1998)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (Mar 9, 1998)
  • K974397 — STERILE SALINE FOR CATHETER CARE (Feb 10, 1998)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (Feb 5, 1998)
  • K972372 — GERM TRAPPER SUCTION TUBE HOLDER (Dec 11, 1997)

FDA data resources