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510(k) K943047

IV START KITS by Sterile Concepts, Inc. — Product Code KMK

K943047 is an FDA 510(k) premarket notification submitted by Sterile Concepts, Inc. for the device "IV START KITS". The FDA issued a decision of Substantially Equivalent on September 14, 1994. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Sterile Concepts, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1994
Date Received
June 27, 1994
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 Sterile Concepts, Inc.

  • K951231 — ORTHOPEDIC PACKS (December 1, 1995)
  • K951081 — OB/GYN PACKS (November 13, 1995)
  • K952539 — RADIOLOGY PACKS (July 14, 1995)
  • K951478 — GENERAL AND PLASTIC SURGERY PACKS (June 13, 1995)
  • K944139 — DENTAL HYGIENE TRAY (December 15, 1994)
  • K943090 — SUTURE REMOVAL TRAYS (August 22, 1994)
  • K940864 — DENTIST WITH ASSISTANT PACK (August 2, 1994)
  • K943046 — SKIN STAPLE REMOVAL TRAYS (July 29, 1994)
  • K920763 — LACERATTION TRAY (September 28, 1992)

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)
  • 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)
  • K940127 — CENTERMARK SECURING WINGS (February 9, 1994)

FDA data resources