Atlas FDA

SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER

FDA 510(k) clearance K940795 · decided 1994-05-24

Clearance details

K-number
K940795
Device name
SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
Applicant
Baxter Edwards
Decision
Substantially Equivalent
Date received
1994-02-22
Decision date
1994-05-24
Days to decision
91 days
Clearance type
Traditional
Product code
DYG
Device class
2
Regulation number
870.1240
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed p recall (Z-1700-2015)Edwards Lifesciences, LLC2015-06-02
EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software release 5.3 recall (Z-1310-06)Edwards Lifesciences Llc2006-08-02