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510(k) K853131

THORO/CATH STRAIGHT THORACIC RIGHT ANGLE by J. H. Emerson Co. — Product Code GBS

K853131 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "THORO/CATH STRAIGHT THORACIC RIGHT ANGLE". The FDA issued a decision of Substantially Equivalent on September 5, 1985. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1985
Date Received
July 26, 1985
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 J. H. Emerson Co.

  • K002598 — EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL (November 22, 2000)
  • K920910 — OXYGEN POWERED RESUSCITATOR FOR CPR (January 12, 1993)
  • K924174 — EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA (November 17, 1992)
  • K902764 — EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM (November 19, 1990)
  • K896721 — MODEL 7-AT TREATMENT CHAMBER (January 22, 1990)
  • K881808 — EMERSON CHEST RESPIRATOR, MODEL 33-CRE (August 4, 1988)
  • K873489 — EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000 (December 29, 1987)
  • K872936 — 97-D EMERSON DIMMER CONTROL (September 24, 1987)
  • K872937 — 97-TD EMERSON TIMER/DIMMER CONTROL (September 24, 1987)
  • K864379 — EMERSON 3MV VOLUME VENTILATOR (December 15, 1986)

Other clearances for product code GBS

  • K912645 — ATRIUMS PDR THORACIC CATHETER (September 13, 1991)
  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • 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)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)
  • K870015 — HCI ALL PURPOSE DRAIN/CATHETER SET (February 6, 1987)

FDA data resources