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510(k) K881873

INTRODUCTION/DRAINAGE CATHETER & ACCESS by Sheridan Catheter Corp. — Product Code GBS

K881873 is an FDA 510(k) premarket notification submitted by Sheridan Catheter Corp. for the device "INTRODUCTION/DRAINAGE CATHETER & ACCESS". The FDA issued a decision of Substantially Equivalent on May 18, 1988. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Sheridan Catheter Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1988
Date Received
May 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Sheridan Catheter Corp.

  • K922894 — LAZER-TRACH TRACHEAL TUBE (May 7, 1993)
  • K897046 — LASER RESISTANT TRACHEAL TUBE (March 23, 1990)
  • K890823 — ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER (May 5, 1989)
  • K884765 — CLINICAL ELECTRONIC THERMOMETERS (February 16, 1989)
  • K882918 — KIM NASO-INTESTINAL TUBE (December 5, 1988)
  • K882127 — CLINICAL ELECTRONIC THERMOMETERS (August 4, 1988)
  • K881368 — CLINICAL ELECTONIC THERMOMETERS (July 13, 1988)
  • K881293 — SHERIDAN ELECTROSURGERY PROTECTION FILTER (June 16, 1988)
  • K880960 — NDYAG LASER TRACHEAL TUBE (April 29, 1988)
  • K875226 — ESOPHAGEAL OBTURATOR/TRACHEAL TUBE (January 19, 1988)

Other clearances for product code GBS

  • K912645 — ATRIUMS PDR THORACIC CATHETER (September 13, 1991)
  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K880895 — URESIL WOUND DRAIN TROCAR (March 14, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K873377 — CLOSED CHEST DRAINAGE SET W/SUTURES (October 28, 1987)
  • K872460 — AN3000 MAHONEY DRAIN (July 23, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K870015 — HCI ALL PURPOSE DRAIN/CATHETER SET (February 6, 1987)
  • K863560 — URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA (September 29, 1986)

FDA data resources