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510(k) K943663

NAVARRE 600 ML DRAINAGE BAG by Navarre Biomedical , Ltd. — Product Code EXF

K943663 is an FDA 510(k) premarket notification submitted by Navarre Biomedical , Ltd. for the device "NAVARRE 600 ML DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on September 8, 1994. The device falls under product code EXF (Bag, Bile Collecting), a Class II device regulated under 21 CFR 876.5010. Navarre Biomedical , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1994
Date Received
July 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Bile Collecting
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Navarre Biomedical , Ltd.

  • K955110 — NAVARRE PERCUTANEOUS BILIARY DRAINAGE (November 7, 1996)
  • K955505 — OPTI-DRAIN MULTI-USE DRAINAGE CATHETER (February 7, 1996)
  • K945909 — NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER (June 2, 1995)
  • K951907 — NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER (May 15, 1995)
  • K951475 — NAVARRE UNIVERSAL DRAINAGE CATHETER (April 24, 1995)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K933600 — NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS (March 28, 1994)
  • K932391 — NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET (January 27, 1994)

Other clearances for product code EXF

  • K003078 — MERIT DRAINAGE DEPOT (December 11, 2000)
  • K990428 — DRAINAGE BAG (August 12, 1999)
  • K980005 — MANAN D BAG (January 30, 1998)
  • K961986 — MANAN D BAG (March 13, 1997)
  • K963849 — MANAN D BAG (December 13, 1996)
  • K911129 — MMG BILE BAG (August 7, 1991)
  • K903449 — URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET (September 12, 1990)
  • K901844 — URESIL TRU-CLOSE DRAINAGE BAG (June 1, 1990)

FDA data resources