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510(k) K862663

TRACHEOSTOMY CARE TRAY by Welmed Systems, Inc. — Product Code LRQ

K862663 is an FDA 510(k) premarket notification submitted by Welmed Systems, Inc. for the device "TRACHEOSTOMY CARE TRAY". The FDA issued a decision of Substantially Equivalent on July 30, 1986. The device falls under product code LRQ (Tracheostomy And Nasal Suctioning Kit), a Class I device. Welmed Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1986
Date Received
July 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tracheostomy And Nasal Suctioning Kit
Device Class
Class I
Regulation Number
Review Panel
SU
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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)
  • K863284 — I.V. START KIT (September 22, 1986)
  • K863283 — CARE + PLUS SUTURE REMOVAL TRAY (September 15, 1986)
  • K862219 — T.P.N. DRESSING CHANGE TRAY (July 8, 1986)

Other clearances for product code LRQ

  • K963720 — TRACHEOSTOMY KIT (November 27, 1996)
  • K961167 — MEDCARE TRACHEOSTOMY CARE TRAY (July 2, 1996)
  • K952925 — READY NURSE SYSTEM (RNS) TRACH CARE KIT (July 12, 1995)
  • K950851 — GENT-L-KARE TRACHEOSTOMY TRAYS (June 21, 1995)
  • K871692 — TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 (June 1, 1987)

FDA data resources