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510(k) K872182

POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE by Polystan C/O Vitalcor, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1987
Date Received
June 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Polystan C/O Vitalcor, Inc.

  • K894657 — POLYSTAN HEART-LUNG MACHINE SYSTEM (March 28, 1990)
  • K893940 — POLYSTAN HEATER-COOLER UNIT (January 18, 1990)
  • K893705 — SAFE-1 VENOUS RESERVOIR (December 22, 1989)
  • K893704 — SAFE-1 (December 22, 1989)
  • K874853 — POLYSTAN TWO STAGE CATHETERS (February 5, 1988)
  • K874852 — POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS (February 5, 1988)
  • K843538 — PO 2 LYTRODE (October 18, 1984)

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