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510(k) K914315

OPTICAL CATHETER INTRODUCER SETS, MODIFICATION by Medical Dynamics, Inc. — Product Code KGX

K914315 is an FDA 510(k) premarket notification submitted by Medical Dynamics, Inc. for the device "OPTICAL CATHETER INTRODUCER SETS, MODIFICATION". The FDA issued a decision of Substantially Equivalent on March 4, 1992. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Medical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1992
Date Received
September 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Medical Dynamics, Inc.

  • K974542 — TRUE VISION, TRUE VISION II (February 17, 1998)
  • K921294 — VIDEO ENDOSCOPE-RIGID MODIFICATION (July 20, 1994)
  • K934682 — SURGICAL VIDEO CAMERA AND ACCESSORIES (February 15, 1994)
  • K930568 — ADAIR/VERESS NEEDLE INTRODUCER SET (July 22, 1993)
  • K915538 — OVER THE WIRE STONE BASKET (March 20, 1992)
  • K913986 — CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM (January 28, 1992)
  • K911296 — OPTICAL CATHETER ARTHROSCOPE (September 24, 1991)
  • K903339 — VIDEO ENDOSCOPE, RIGID (March 6, 1991)
  • K904609 — XENON LIGHT SOURCE (December 18, 1990)
  • K904113 — OPERATIVE RECORDING CAMERA (October 30, 1990)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources