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510(k) K951506

SUCTION CATHETER KIT, STERILE, SINGLE-USE by Trinity Laboratories, Inc. — Product Code BSY

K951506 is an FDA 510(k) premarket notification submitted by Trinity Laboratories, Inc. for the device "SUCTION CATHETER KIT, STERILE, SINGLE-USE". The FDA issued a decision of Substantially Equivalent on July 3, 1995. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Trinity Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1995
Date Received
April 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Suction, Tracheobronchial
Device Class
Class I
Regulation Number
868.6810
Review Panel
AN
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 BSY

  • K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (November 25, 2003)
  • K992902 — AMBU HAND POWER SUCTION PUMP (October 25, 1999)
  • K982945 — DUAL PURPOSE CLOSED CATHETER (September 22, 1998)
  • K981910 — SUCTION CATHETER (August 24, 1998)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K961707 — TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (March 11, 1997)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K960488 — NEO 2 LINE SUCTION SYSTEM (April 26, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)

FDA data resources