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510(k) K924249

DERMASSIST TRANSPARENT SITE DRESSING by Wilshire Medical Products — Product Code KMK

K924249 is an FDA 510(k) premarket notification submitted by Wilshire Medical Products for the device "DERMASSIST TRANSPARENT SITE DRESSING". The FDA issued a decision of Substantially Equivalent on February 3, 1993. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Wilshire Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1993
Date Received
August 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Intravascular Catheter Securement
Device Class
Class I
Regulation Number
880.5210
Review Panel
HO
Submission Type

Other clearances by Wilshire Medical Products

  • K946031 — DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING (February 27, 1995)
  • K946030 — DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING (February 27, 1995)
  • K944333 — HYDRODERM GEL WOUND DRESSING (November 10, 1994)
  • K941149 — DERMAASSIST HYDROCOLLOID DRESSING (May 20, 1994)
  • K941216 — HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING (May 20, 1994)
  • K941005 — DERMASSIST(TM) XEROFORM PETROLATUM DRESSING (April 14, 1994)
  • K940044 — DERMASSIST WET DRESSING, SALINE (March 3, 1994)
  • K936234 — DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING (March 3, 1994)
  • K936230 — DERMASSIST PETROLATUM GAUZE,USP (March 3, 1994)
  • K940076 — DERMASSIST WET DRESSING, WATER (March 3, 1994)

Other clearances for product code KMK

  • K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, Sec (July 9, 2019)
  • K981860 — A P HARNESS (June 3, 1999)
  • K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER (October 11, 1996)
  • K941098 — SECURE-SITE (August 9, 1995)
  • K943147 — STATLOCK CV (September 29, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K941940 — IMMOBILE STERILE AND IMMOBILE A/C STERILE (July 14, 1994)
  • K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (July 14, 1994)
  • K935389 — CONMED VENI-GARD I.V. DRESSING (March 7, 1994)
  • K935252 — K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (February 18, 1994)

FDA data resources