Cleared Traditional

PORT-A-CATH ACCESS KIT

K952201 · Medi-Flex Hospital Products, Inc. · General Hospital
Oct 1995
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K952201 is an FDA 510(k) clearance for the PORT-A-CATH ACCESS KIT, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on October 4, 1995, 147 days after receiving the submission on May 10, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K952201 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1995
Decision Date October 04, 1995
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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