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K Number
K103367
Device Name
SEEKER CROSSING SUPPORT CATHETER
Manufacturer
BARD PERIPHERAL VASCULAR, INC.
Date Cleared
2010-12-08

(22 days)

Product Code
DQY
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Seeker™ Crossing Support Catheters are recommended for guidewire exchange and infusion devices designed for use in the peripheral vascular system. The catheters are intended to support a guidewire during access into the vasculature, allow for guidewire exchanges, and provide a passage for delivery of saline solutions and/or diagnostic contrast agents.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter for the Seeker Crossing Support Catheter, a medical device. It does not contain information about acceptance criteria, device performance, or study details.

Therefore, I cannot provide the requested information. The document primarily confirms that the FDA has found the device substantially equivalent to pre-existing legally marketed devices.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).