Cleared Traditional

HAEMONETICS 170 Y INFUSION SET

K810365 · Haemonetics Corp. · General Hospital
Mar 1981
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K810365 is an FDA 510(k) clearance for the HAEMONETICS 170 Y INFUSION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Haemonetics Corp. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981, 47 days after receiving the submission on February 12, 1981. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K810365 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1981
Decision Date March 31, 1981
Days to Decision 47 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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