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510(k) K802538

BASIN PACK by Texas Medical Products, Inc. — Product Code FNY

K802538 is an FDA 510(k) premarket notification submitted by Texas Medical Products, Inc. for the device "BASIN PACK". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code FNY (Basin, Emesis), a Class I device regulated under 21 CFR 880.6730. Texas Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Basin, Emesis
Device Class
Class I
Regulation Number
880.6730
Review Panel
HO
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)
  • K810395 — PRE-BYPASS FILTER (March 5, 1981)
  • K802544 — DISPOSABLE QUICK RELEASE PERFUSION ADAP (January 16, 1981)
  • K802539 — DISPOSABLE GAS LINE FILTER (January 16, 1981)

Other clearances for product code FNY

  • K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS (April 23, 1984)
  • K800440 — STERILE SPONGE BOWLS (April 29, 1980)
  • K792625 — STERILIZATION PROCESS/PLACENTA BASIN (January 16, 1980)
  • K771733 — 8 EMESIS BASIN (September 28, 1977)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)
  • K760085 — BASIN, STERILE (#3200) (July 20, 1976)

FDA data resources