POLYSTAN HEART-LUNG MACHINE SYSTEM— 510(k) K894657

Name: FDA 510(k) clearance K894657
Creator: U.S. Food and Drug Administration
Published: 1990-03-28

Substantially Equivalent

Polystan C/O Vitalcor, Inc.

FDA 510(k) clearance K894657 for POLYSTAN HEART-LUNG MACHINE SYSTEM, Substantially Equivalent on 1990-03-28. Applicant: Polystan C/O Vitalcor, Inc.. Device class: 2.

Clearance details

Applicant: Polystan C/O Vitalcor, Inc.
Product code: Code DJQ
Device class: Class 2
Regulation: 21 CFR 862.3670
Advisory panel: Clinical Toxicology
Date received: 1989-07-24
Decision date: 1990-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

More clearances from Polystan C/O Vitalcor, Inc.

view all

K893940 — POLYSTAN HEATER-COOLER UNIT1990-01-18
K893704 — SAFE-11989-12-22
K893705 — SAFE-1 VENOUS RESERVOIR1989-12-22
K874852 — POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS1988-02-05
K874853 — POLYSTAN TWO STAGE CATHETERS1988-02-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.