Home / 510(k) Clearances / K893704

510(k) K893704

SAFE-1 by Polystan C/O Vitalcor, Inc. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1989
Date Received
May 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
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)
  • 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)

Other clearances for product code DTZ

  • K253838 — Lifemotion Disposable Membrane Oxygenator (March 16, 2026)
  • K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Bl (March 12, 2026)
  • K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (December 12, 2025)
  • K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (November 24, 2025)
  • K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator V (September 12, 2024)
  • K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac (July 10, 2024)
  • K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity (June 12, 2024)
  • K231652 — D100 KIDS; D101 KIDS (November 16, 2023)
  • K231773 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quant (November 8, 2023)
  • K231414 — CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (November 1, 2023)