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510(k) K882694

FIXATION DEVICE, TRACH TUBE by Bioseal — Product Code CBH

K882694 is an FDA 510(k) premarket notification submitted by Bioseal for the device "FIXATION DEVICE, TRACH TUBE". The FDA issued a decision of Substantially Equivalent on August 15, 1988. The device falls under product code CBH (Device, Fixation, Tracheal Tube), a Class I device regulated under 21 CFR 868.5770. Bioseal has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1988
Date Received
June 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Tracheal Tube
Device Class
Class I
Regulation Number
868.5770
Review Panel
AN
Submission Type

Other clearances by Bioseal

  • K893814 — SURGICAL INSTRUMENT KIT, DISPOSABLE (August 10, 1989)
  • K882695 — RUBBER BAND, STERILE (October 13, 1988)
  • K882696 — DERMICEL, MONTGOMERY STRAP (August 26, 1988)
  • K882709 — TONSIL SPONGE, X-RAY DETECTABLE, W/STRING (August 3, 1988)
  • K882711 — GAUZE SPONGE 12PLY (August 3, 1988)
  • K882712 — STICK SPONGE (August 3, 1988)
  • K882707 — GAUZE PACKING, X-RAY DETECTABLE (August 3, 1988)
  • K882708 — GAUZE SPONGE, X-RAY DETECTABLE (August 3, 1988)
  • K882710 — INTESTINAL SPONGES (August 3, 1988)

Other clearances for product code CBH

  • K140097 — AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM (September 24, 2014)
  • K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/280 (January 28, 1997)
  • K942529 — HCI TUBE STABILIZER (June 14, 1995)
  • K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (April 24, 1995)
  • K950930 — TRACHE-TITE (March 22, 1995)
  • K950318 — FLEX BLUE (February 13, 1995)
  • K942395 — ENDOTRACHEAL TUBE HOLDER (June 30, 1994)
  • K934288 — HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (June 9, 1994)
  • K942016 — TRACH TIE, VENTILATOR TUBING HOLDER (May 24, 1994)
  • K941384 — TRAKEEZ (April 19, 1994)

FDA data resources