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510(k) K832865

FLEX BUBBLE TUBING by Sheridan Catheter Corp. — Product Code BYY

K832865 is an FDA 510(k) premarket notification submitted by Sheridan Catheter Corp. for the device "FLEX BUBBLE TUBING". The FDA issued a decision of Substantially Equivalent on Sep 29, 1983. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Sheridan Catheter Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 29, 1983
Date Received
Aug 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Aspirating, Flexible, Connecting
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Sheridan Catheter Corp.

  • K922894 — LAZER-TRACH TRACHEAL TUBE (May 7, 1993)
  • K897046 — LASER RESISTANT TRACHEAL TUBE (Mar 23, 1990)
  • K890823 — ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER (May 5, 1989)
  • K884765 — CLINICAL ELECTRONIC THERMOMETERS (Feb 16, 1989)
  • K882918 — KIM NASO-INTESTINAL TUBE (Dec 5, 1988)
  • K882127 — CLINICAL ELECTRONIC THERMOMETERS (Aug 4, 1988)
  • K881368 — CLINICAL ELECTONIC THERMOMETERS (Jul 13, 1988)
  • K881293 — SHERIDAN ELECTROSURGERY PROTECTION FILTER (Jun 16, 1988)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880960 — NDYAG LASER TRACHEAL TUBE (Apr 29, 1988)

Other clearances for product code BYY

  • K960616 — VITAFLOW SUCTION/ASPIRATION TUBING SET (May 6, 1996)
  • K960218 — CONNECTING TUBING (Mar 28, 1996)
  • K955149 — MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL (Jan 24, 1996)
  • K955151 — MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR (Jan 24, 1996)
  • K955150 — MAXI-FLOW (Jan 23, 1996)
  • K922989 — WILTEK IRRIGAITON/ASPIRATION TUBE SET (Feb 15, 1994)
  • K911586 — GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) (Jul 2, 1991)
  • K901761 — STERILE SUCTION TUBING SET (May 7, 1990)
  • K873463 — VAN DELLEN ASPIRATING TUBING (Nov 23, 1987)
  • K853296 — EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN (Aug 15, 1985)

FDA data resources