POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE— 510(k) K872182

Name: FDA 510(k) clearance K872182
Creator: U.S. Food and Drug Administration
Published: 1987-10-30

Substantially Equivalent

Polystan C/O Vitalcor, Inc.

FDA 510(k) clearance K872182 for POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE, Substantially Equivalent on 1987-10-30. Applicant: Polystan C/O Vitalcor, Inc.. Device class: 2.

Clearance details

Applicant: Polystan C/O Vitalcor, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1987-06-08
Decision date: 1987-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

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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

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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