Cleared Traditional

K991759 - MAERSK MEDICAL CONTOUR INFUSION SET
(FDA 510(k) Clearance)

K991759 · Maersk Medical A/S · General Hospital

Jun 1999

Decision

32d

Days

Class 2

Risk

K991759 is an FDA 510(k) clearance for the MAERSK MEDICAL CONTOUR INFUSION SET. This device is classified as a Set, Administration, Intravascular (Class II — Special Controls, product code FPA).

Submitted by Maersk Medical A/S (Sylmar, US). The FDA issued a Cleared decision on June 25, 1999, 32 days after receiving the submission on May 24, 1999.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K991759 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 1999
Decision Date	June 25, 1999
Days to Decision	32 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF