Cleared Traditional

PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380

K002138 · Maersk Medical A/S · General Hospital
Aug 2000
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K002138 is an FDA 510(k) clearance for the PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380, 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 August 29, 2000, 43 days after receiving the submission on July 17, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K002138 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2000
Decision Date August 29, 2000
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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