Cleared Traditional

CATCO FIRST PICC

K944504 · Catco Medical, Inc. · General Hospital
Mar 1995
Decision
198d
Days
Class 2
Risk

About This 510(k) Submission

K944504 is an FDA 510(k) clearance for the CATCO FIRST PICC, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Catco Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 31, 1995, 198 days after receiving the submission on September 14, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K944504 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1994
Decision Date March 31, 1995
Days to Decision 198 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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