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510(k) K813587

DISPOSABLE THORACIC CATHETER by Texas Medical Products, Inc. — Product Code GBS

K813587 is an FDA 510(k) premarket notification submitted by Texas Medical Products, Inc. for the device "DISPOSABLE THORACIC CATHETER". The FDA issued a decision of Substantially Equivalent on January 12, 1982. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Texas Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1982
Date Received
December 28, 1981
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 Texas Medical Products, Inc.

  • K893417 — SURGIFRESH SUB-MICRON MASK NO. 901008-000 (June 22, 1989)
  • K870932 — SURGIFRESH SURGICAL SMOKE REMOVAL (March 31, 1987)
  • K851575 — DR. BRUNO LNAGE MINI PHOTOMETER (October 18, 1985)
  • K830634 — CARDIOTOMY FILTER (June 30, 1983)
  • K810532 — DISPOSABLE STOPCOCK (April 23, 1981)
  • K810515 — DISPOSABLE 2-STAGE CANNULA (April 23, 1981)
  • K810395 — PRE-BYPASS FILTER (March 5, 1981)
  • K802544 — DISPOSABLE QUICK RELEASE PERFUSION ADAP (January 16, 1981)
  • K802539 — DISPOSABLE GAS LINE FILTER (January 16, 1981)
  • K802541 — DISPOSABLE PARALLEL Y CONNECTORS (January 16, 1981)

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