Cleared Traditional

EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET

K010197 · Exelint International, Co. · General Hospital
May 2001
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K010197 is an FDA 510(k) clearance for the EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on May 14, 2001, 112 days after receiving the submission on January 22, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K010197 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2001
Decision Date May 14, 2001
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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