SAFE-1 VENOUS RESERVOIR— 510(k) K893705

Name: FDA 510(k) clearance K893705
Creator: U.S. Food and Drug Administration
Published: 1989-12-22

Substantially Equivalent

Polystan C/O Vitalcor, Inc.

FDA 510(k) clearance K893705 for SAFE-1 VENOUS RESERVOIR, Substantially Equivalent on 1989-12-22. Applicant: Polystan C/O Vitalcor, Inc.. Device class: 2.

Clearance details

Applicant: Polystan C/O Vitalcor, Inc.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1989-05-18
Decision date: 1989-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

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

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.