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510(k) K842999

VENI-SHIELD by U.S. Mfg. & Management, Inc. — Product Code KMK

K842999 is an FDA 510(k) premarket notification submitted by U.S. Mfg. & Management, Inc. for the device "VENI-SHIELD". The FDA issued a decision of Substantially Equivalent on September 24, 1984. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. U.S. Mfg. & Management, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1984
Date Received
July 30, 1984
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 U.S. Mfg. & Management, Inc.

  • K920860 — CONTROLLED PASSIVE MOTION MACHINE (April 2, 1992)
  • K874436 — FLUID SAMPLING PACK (January 5, 1988)
  • K862335 — MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT (July 24, 1986)
  • K853242 — I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI (August 30, 1985)

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)
  • K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (July 14, 1994)
  • K941940 — IMMOBILE STERILE AND IMMOBILE A/C 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