Home / 510(k) Clearances / K810395

510(k) K810395

PRE-BYPASS FILTER by Texas Medical Products, Inc. — Product Code KRJ

K810395 is an FDA 510(k) premarket notification submitted by Texas Medical Products, Inc. for the device "PRE-BYPASS FILTER". The FDA issued a decision of Substantially Equivalent on March 5, 1981. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Texas Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1981
Date Received
February 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Prebypass, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4280
Review Panel
CV
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)
  • K813587 — DISPOSABLE THORACIC CATHETER (January 12, 1982)
  • K810532 — DISPOSABLE STOPCOCK (April 23, 1981)
  • K810515 — DISPOSABLE 2-STAGE CANNULA (April 23, 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 KRJ

  • K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (October 1, 1999)
  • K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (February 1, 1999)
  • K940126 — AVECOR PRE-BYPASS FILTER (June 28, 1994)
  • K900672 — PREBYPASS FILTER, CAT. NO. FPB-5 (April 3, 1990)
  • K885154 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM (February 22, 1989)
  • K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (December 21, 1988)
  • K884244 — INTERSEPT* PREBYPASS FILTER (December 5, 1988)
  • K883086 — INTERSEPT*PREBYPASS FILTER (September 16, 1988)
  • K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K871350 — PREBYPASS FILTER (June 8, 1987)

FDA data resources