Cleared Traditional

HEART CATH TRAY, STERILE, DISPOSABLE

K981441 · Trinity Laboratories, Inc. · Cardiovascular
Jul 1998
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K981441 is an FDA 510(k) clearance for the HEART CATH TRAY, STERILE, DISPOSABLE, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on July 10, 1998, 80 days after receiving the submission on April 21, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K981441 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 1998
Decision Date July 10, 1998
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

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