Cleared Special

INTERLINK THREADED LOCK CANNULA

K011858 · Bd · General Hospital
Jun 2001
Decision
5d
Days
Class 2
Risk

About This 510(k) Submission

K011858 is an FDA 510(k) clearance for the INTERLINK THREADED LOCK CANNULA, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on June 19, 2001, 5 days after receiving the submission on June 14, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K011858 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2001
Decision Date June 19, 2001
Days to Decision 5 days
Submission Type Special
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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