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510(k) K863284

I.V. START KIT by Welmed Systems, Inc.

K863284 is an FDA 510(k) premarket notification submitted by Welmed Systems, Inc. for the device "I.V. START KIT". The FDA issued a decision of Substantially Equivalent (with conditions) on September 22, 1986. Welmed Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
September 22, 1986
Date Received
August 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Welmed Systems, Inc.

  • K863282 — CARE + PLUS CATHETER CARE TRAY (October 31, 1986)
  • K863281 — CARE + PLUS IRREGATION TRAY (October 31, 1986)
  • K863497 — SUCTION CATHETER KIT (October 6, 1986)
  • K863283 — CARE + PLUS SUTURE REMOVAL TRAY (September 15, 1986)
  • K862663 — TRACHEOSTOMY CARE TRAY (July 30, 1986)
  • K862219 — T.P.N. DRESSING CHANGE TRAY (July 8, 1986)

FDA data resources