Cleared Traditional

8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS

K921755 · Davol, Inc. · General Hospital
Oct 1992
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K921755 is an FDA 510(k) clearance for the 8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 23, 1992, 193 days after receiving the submission on April 13, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K921755 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1992
Decision Date October 23, 1992
Days to Decision 193 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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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