PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES— 510(k) K072364

Name: FDA 510(k) clearance K072364
Creator: U.S. Food and Drug Administration
Published: 2007-09-19

Substantially Equivalent

Pulsion Medical Systems AG

FDA 510(k) clearance K072364 for PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES, Substantially Equivalent on 2007-09-19. Applicant: Pulsion Medical Systems AG. Device class: 2.

Clearance details

Applicant: Pulsion Medical Systems AG
Product code: Code KRB
Device class: Class 2
Regulation: 21 CFR 870.1915
Advisory panel: Cardiovascular
Date received: 2007-08-22
Decision date: 2007-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Wake Forest, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRB

view all

K171620 — PiCCO Catheter2018-02-21
K100739 — VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R52010-12-07
K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 40462002-05-23
K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR2000-05-11
K936182 — CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT1994-03-25

More clearances from Pulsion Medical Systems AG

view all

K091786 — PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)2010-06-18
K072735 — PULSION PICCO-2, MODEL 85002007-10-18
K060898 — PULSION PICCO PLUS, MODEL 81002006-07-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.