Cleared Traditional

K912629 - DATASCOPE SYSTEM 95 (FDA 510(k) Clearance)

K912629 · Datascope Corp. · Cardiovascular device
Mar 1992
Decision
268d
Days
Class 2
Risk

K912629 is an FDA 510(k) clearance for the DATASCOPE SYSTEM 95. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on March 11, 1992, 268 days after receiving the submission on June 17, 1991.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K912629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1991
Decision Date March 11, 1992
Days to Decision 268 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DSP - System, Balloon, Intra-aortic And Control
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.3535