Cleared Traditional

K932370 - REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET (FDA 510(k) Clearance)

K932370 · Remington Medical, Inc. · Cardiovascular device

Nov 1993

Decision

179d

Days

Class 2

Risk

K932370 is an FDA 510(k) clearance for the REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).

Submitted by Remington Medical, Inc. (Atlanta, US). The FDA issued a Cleared decision on November 9, 1993, 179 days after receiving the submission on May 14, 1993.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K932370 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 14, 1993
Decision Date	November 09, 1993
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement