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510(k) K921464

CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT by Trinity Laboratories, Inc. — Product Code GBQ

K921464 is an FDA 510(k) premarket notification submitted by Trinity Laboratories, Inc. for the device "CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT". The FDA issued a decision of Substantially Equivalent on May 5, 1992. The device falls under product code GBQ (Catheter, Continuous Irrigation), a Class I device regulated under 21 CFR 878.4200. Trinity Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1992
Date Received
March 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Trinity Laboratories, Inc.

  • K981441 — HEART CATH TRAY, STERILE, DISPOSABLE (July 10, 1998)
  • K974238 — DENTAL TRAY, STERILE, DISPOSABLE (February 4, 1998)
  • K974286 — CIRCUMCISION TRAY, CAT. NO. 70340 (December 12, 1997)
  • K972160 — CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATIO (August 1, 1997)
  • K970722 — EYE TRAY (March 31, 1997)
  • K965201 — O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (February 14, 1997)
  • K964921 — BASIC BIOPSY TRAY. DISPOSABLE, STERILE (January 22, 1997)
  • K953929 — MID-STREAM COLLECTION SET-STERILE (November 16, 1995)
  • K952058 — STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE (September 21, 1995)
  • K953070 — WOUNDFOAM 4 X 4 (September 8, 1995)

Other clearances for product code GBQ

  • K941356 — MICROFLOW IRRIGATION SYSTEM (May 19, 1994)
  • K882647 — GESCO CATHETERIZATION TRAY (September 9, 1988)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K872787 — MODIFIED CURLCATH (August 4, 1987)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K771732 — THORNTON ANTERIOR CHAMBER IRRIGATOR (September 28, 1977)

FDA data resources