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510(k) K973364

4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG by Maersk Medical A/S — Product Code KNX

K973364 is an FDA 510(k) premarket notification submitted by Maersk Medical A/S for the device "4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on March 17, 1998. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Maersk Medical A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1998
Date Received
September 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Maersk Medical A/S

  • K011071 — PARADIGM QUICK-SET INFUSION SET (June 7, 2001)
  • K004028 — ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING (March 27, 2001)
  • K002138 — PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 (August 29, 2000)
  • K990110 — DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 (December 6, 1999)
  • K990115 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 (December 6, 1999)
  • K990113 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 45 (December 6, 1999)
  • K990112 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 (December 6, 1999)
  • K990111 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 (December 6, 1999)
  • K990810 — ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING (September 17, 1999)
  • K991759 — MAERSK MEDICAL CONTOUR INFUSION SET (June 25, 1999)

Other clearances for product code KNX

  • K110518 — IBAG (June 24, 2011)
  • K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (December 11, 1997)
  • K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM (August 18, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (April 19, 1996)
  • K952208 — PROSYS LEG BAG (August 15, 1995)

FDA data resources