Home / 510(k) Clearances / K874470

510(k) K874470

MWI 400 WOUND DRESSING by Med-West, Inc. — Product Code NAD

K874470 is an FDA 510(k) premarket notification submitted by Med-West, Inc. for the device "MWI 400 WOUND DRESSING". The FDA issued a decision of SN on December 18, 1987. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Med-West, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
December 18, 1987
Date Received
November 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Med-West, Inc.

  • K880877 — CONTRAST INJECTION DEVICE (May 31, 1988)
  • K880398 — POWER TOILET ELEVATOR (March 17, 1988)
  • K872724 — SHEATH/DILATORS (September 15, 1987)
  • K854612 — ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 (January 3, 1986)
  • K852162 — MNI 400 INJECTION CAPS (June 12, 1985)
  • K842342 — MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN (June 14, 1984)
  • K832124 — CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI (August 12, 1983)
  • K831828 — TEFLON FEMORAL CATHETER MWI 100,10 & (July 7, 1983)
  • K831440 — SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 (June 3, 1983)
  • K831401 — SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS (June 3, 1983)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources