Cleared Traditional

K954422 - PER-Q-CATH MID-LINE
(FDA 510(k) Clearance)

K954422 · Gesco Intl., Inc. · General Hospital
Dec 1995
Decision
85d
Days
Class 2
Risk

K954422 is an FDA 510(k) clearance for the PER-Q-CATH MID-LINE, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Gesco Intl., Inc. (Woburn, US). The FDA issued a Cleared decision on December 15, 1995, 85 days after receiving the submission on September 21, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K954422 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1995
Decision Date December 15, 1995
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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