Cleared Traditional

INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER

K924737 · Becton Dickinson Vascular Access, Inc. · Cardiovascular

Aug 1993

Decision

335d

Days

Class 2

Risk

About This 510(k) Submission

K924737 is an FDA 510(k) clearance for the INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER, 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 August 23, 1993, 335 days after receiving the submission on September 22, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number	K924737 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 1992
Decision Date	August 23, 1993
Days to Decision	335 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF