Name: Predicase
Price: 199 USD

K-number	K233983
Device name	Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
Applicant	Edwards Lifesciences
Product code	DYG
Device class	Class II
Decision date	Jun 27, 2024
Decision	Substantially Equivalent
Regulation	870.1240

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Source

View the full FDA submission: accessdata.fda.gov

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Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)

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