Cleared Traditional

IMPACT TURBO CATH

K851611 · Impact Instrumentation, Inc. · General Hospital
Jun 1985
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K851611 is an FDA 510(k) clearance for the IMPACT TURBO CATH, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Impact Instrumentation, Inc. (Bogota, US). The FDA issued a Cleared decision on June 5, 1985, 57 days after receiving the submission on April 9, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K851611 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1985
Decision Date June 05, 1985
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code JOL — Catheter And Tip, Suction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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