(166 days)
The intended use is to facilitate the placement of other devices such as guidewires, central venous catheters, peripherally inserted central venous catheters, and probes in the vascular system.
The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle.
This document (K954906) is a 510(k) premarket notification for an introducer catheter. It outlines the device description, intended use, and comparison to predicate devices for demonstrating substantial equivalence. It does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or AI-related aspects.
Therefore, I cannot provide the requested information as it is not present in the provided text.
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K954906
SUMMARY OF SAFETY AND EFFICACY
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A. The submitter's name, address, telephone number, contact person, and date of preparation.
Submitted by Becton Dickinson Vascular Access, 9450 South State Street, Sandy, UT 84070. Contact: C. J. Welle. Telephone: 801-565-2535. Prepared: October 24, 1995. -
B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.
Name: Introducer Catheter Brand: FIRST PICC™ Common Name: Introducer Catheter Classification Name: Intravascular Catheter (80 FOZ) -
C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:
Predicate Device: The Becton Dickinson Vascular Access INSYTE® brand and SPLIT SECOND® brand introducer catheters and the Teleflex, Inc. Percutaneous Introducer Set. -
D. A description of the device that is the subject of the Premarket Notification submission.
The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle. -
E. Statement of intended use of the device.
The intended use is to facilitate the placement of other devices such as guidewires, central venous catheters, peripherally inserted central venous catheters, and probes in the vascular system. -
F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above.
The proposed catheter differs from the INSYTE® brand introducer catheter in that it is splittable; however, the intended use is the same. It is similar to the SPLIT SECOND® brand introducer catheter and the Teleflex, Inc. Percutaneous Introducer Set in that both are splittable and both are introducer catheters.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).