Home / 510(k) Clearances / K896421

510(k) K896421

TRANSPARENT FILM I.V. SITE/WOUND DRESSING by Catalina Biomedical Corp. — Product Code KMK

K896421 is an FDA 510(k) premarket notification submitted by Catalina Biomedical Corp. for the device "TRANSPARENT FILM I.V. SITE/WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on January 31, 1990. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Catalina Biomedical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1990
Date Received
November 8, 1989
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 Catalina Biomedical Corp.

  • K920050 — BIOLEX WOUND GEL, (April 7, 1992)
  • K913480 — WOUND CARE TRAY A (October 18, 1991)
  • K913479 — WOUND CARE TRAY B (October 8, 1991)
  • K896358 — VARI/MOIST WOUND DRESSING (February 1, 1990)

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