Name: Predicase
Price: 199 USD

K-number	K232258
Device name	XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
Applicant	Transit Scientific, LLC
Product code	PNO
Device class	Class II
Decision date	Jun 17, 2024
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter

Everything you need for a 510(k) submission. Nothing you don't.

XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter