Cleared Special

K063525 - DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
(FDA 510(k) Clearance)

K063525 · Datascope Corp. · Cardiovascular

Jan 2007

Decision

44d

Days

Class 2

Risk

K063525 is an FDA 510(k) clearance for the DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM. This device is classified as a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP).

Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on January 5, 2007, 44 days after receiving the submission on November 22, 2006.

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

Submission Details

510(k) Number	K063525 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2006
Decision Date	January 05, 2007
Days to Decision	44 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF