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510(k) K910693

PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET by Baxter Healthcare Corp — Product Code JOL

K910693 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET". The FDA issued a decision of Substantially Equivalent on Oct 17, 1991. 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 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 17, 1991
Date Received
Feb 19, 1991
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
510(k) Exempt

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Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121… (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… (May 1, 2001)
  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (Oct 25, 2000)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (Mar 9, 1998)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 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

Source: FDA 510(k) database entry for K910693. Report a data issue: hello@regdatalab.com.