Cleared Traditional

SYNERGY CT PICC

K101329 · Health Line International Corporation · General Hospital
Aug 2010
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K101329 is an FDA 510(k) clearance for the SYNERGY CT PICC, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Health Line International Corporation (Centerville, US). The FDA issued a Cleared decision on August 19, 2010, 99 days after receiving the submission on May 12, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K101329 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2010
Decision Date August 19, 2010
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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