Cleared Traditional

K803238 - INTRAVASCULAR CATHETER
(FDA 510(k) Clearance)

K803238 · G.D. Searle and Co. · General Hospital

Apr 1981

Decision

121d

Days

Class 2

Risk

K803238 is an FDA 510(k) clearance for the INTRAVASCULAR CATHETER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981, 121 days after receiving the submission on December 23, 1980. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K803238 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1980
Decision Date	April 23, 1981
Days to Decision	121 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

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