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510(k) K862563

TRACHEOSTOMY CLEANSING SOLUTION by Clinipad Corp. — Product Code EPE

K862563 is an FDA 510(k) premarket notification submitted by Clinipad Corp. for the device "TRACHEOSTOMY CLEANSING SOLUTION". The FDA issued a decision of Substantially Equivalent on July 15, 1986. The device falls under product code EPE (Brush, Cleaning, Tracheal Tube), a Class I device regulated under 21 CFR 868.5795. Clinipad Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1986
Date Received
July 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Cleaning, Tracheal Tube
Device Class
Class I
Regulation Number
868.5795
Review Panel
AN
Submission Type

Other clearances by Clinipad Corp.

  • K931560 — CARDIAC CATHETERIZATION TRAY (July 11, 1994)
  • K931668 — PICC INSERTION TRAY (March 7, 1994)
  • K932071 — I.V. START KIT (February 17, 1994)
  • K932010 — V.A.D. ACCESS KIT (February 3, 1994)
  • K932036 — LACERATION TRAY (December 13, 1993)
  • K932016 — TRACHEOSTOMY CARE TRAY (November 3, 1993)
  • K862562 — PUNCH BIOPSY KIT (October 7, 1986)
  • K833075 — WET DRESSING KIT (January 27, 1984)
  • K833432 — CATHETER INSERTION KIT (December 28, 1983)
  • K830476 — OR PREP KIT (March 31, 1983)

Other clearances for product code EPE

  • K863635 — UPDATED STERILE ENDOTRACHEAL BRUSHES (November 3, 1986)

FDA data resources