SARNS SAFETY LOOP— 510(k) K863593

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K863593 for SARNS SAFETY LOOP, Substantially Equivalent on 1986-11-18. Applicant: 3M Health Care, Sarns. Device class: 2.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code DWD
Device class: Class 2
Regulation: 21 CFR 870.4430
Advisory panel: Cardiovascular
Date received: 1986-09-15
Decision date: 1986-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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K941653 — SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION1994-08-24
K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION1994-07-26

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