Cleared Traditional

K941283 - INNERSENSE DISPOSABLE MICROTRANSDUCER
(FDA 510(k) Clearance)

K941283 · Becton Dickinson Vascular Access, Inc. · Cardiovascular

Apr 1994

Decision

33d

Days

Class 2

Risk

K941283 is an FDA 510(k) clearance for the INNERSENSE DISPOSABLE MICROTRANSDUCER. This device is classified as a Transducer, Pressure, Catheter Tip (Class II — Special Controls, product code DXO).

Submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on April 19, 1994, 33 days after receiving the submission on March 17, 1994.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number	K941283 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1994
Decision Date	April 19, 1994
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF