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510(k) K894657

POLYSTAN HEART-LUNG MACHINE SYSTEM by Polystan C/O Vitalcor, Inc. — Product Code DJQ

K894657 is an FDA 510(k) premarket notification submitted by Polystan C/O Vitalcor, Inc. for the device "POLYSTAN HEART-LUNG MACHINE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 28, 1990. The device falls under product code DJQ (Test Reagents For Phenothiazine), a Class II device regulated under 21 CFR 862.3670. Polystan C/O Vitalcor, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1990
Date Received
July 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test Reagents For Phenothiazine
Device Class
Class II
Regulation Number
862.3670
Review Panel
TX
Submission Type

Other clearances by Polystan C/O Vitalcor, Inc.

  • K893940 — POLYSTAN HEATER-COOLER UNIT (January 18, 1990)
  • K893704 — SAFE-1 (December 22, 1989)
  • K893705 — SAFE-1 VENOUS RESERVOIR (December 22, 1989)
  • K874853 — POLYSTAN TWO STAGE CATHETERS (February 5, 1988)
  • K874852 — POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS (February 5, 1988)
  • K872182 — POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE (October 30, 1987)
  • K843538 — PO 2 LYTRODE (October 18, 1984)

FDA data resources