Cleared Traditional

PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR

K991886 · Pulsion Medical Systems, Inc. · Cardiovascular

May 2000

Decision

344d

Days

Class 2

Risk

About This 510(k) Submission

K991886 is an FDA 510(k) clearance for the PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR, a Probe, Thermodilution (Class II — Special Controls, product code KRB), submitted by Pulsion Medical Systems, Inc. (Wilmington, US). The FDA issued a Cleared decision on May 11, 2000, 344 days after receiving the submission on June 2, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1915.

Submission Details

510(k) Number	K991886 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1999
Decision Date	May 11, 2000
Days to Decision	344 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF