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510(k) K912211

INTRAVASCULAR CATHETER SECURMENT DEVICE by Inman Liebelt Corp. — Product Code KMK

K912211 is an FDA 510(k) premarket notification submitted by Inman Liebelt Corp. for the device "INTRAVASCULAR CATHETER SECURMENT DEVICE". The FDA issued a decision of Substantially Equivalent on August 9, 1991. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Inman Liebelt Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
May 20, 1991
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 Inman Liebelt Corp.

  • K912146 — URETERAL CATHETER HOLDER (July 26, 1991)
  • K905590 — UCEZ - STERILE LENS FOG REDUCTION DEVICE (May 10, 1991)
  • K905583 — ILC FORCEPS PADS (April 12, 1991)
  • K903611 — ILC LEG BAG HOLDER (October 26, 1990)
  • K903610 — O.R. TIP CLEANER (October 19, 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