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510(k) K022584

CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING by Cardiotech Intl. — Product Code MGQ

K022584 is an FDA 510(k) premarket notification submitted by Cardiotech Intl. for the device "CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on December 30, 2002. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2002
Date Received
August 5, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances for product code MGQ

  • K171879 — HylaGuard Moisturizing Cream (October 16, 2017)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (March 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (July 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)
  • K040517 — TENDERWET ACTIVE (March 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (August 22, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K022995 — COLLATEK HYDROGEL (December 2, 2002)

FDA data resources