(89 days)
The Cordis ST Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The Cordis ST Steerable Guidewire incorporates a stainless steel corewire and radiopaque coil. The shaft is coated with PTFE.
This document describes a premarket notification for a medical device (Cordis ST Steerable Guidewire). It does not contain information about software or AI, nor does it detail a study involving acceptance criteria for device performance. Instead, it focuses on general device description, classification, and biocompatibility.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. These details are typically found in documents related to performance testing, often for software-based medical devices or devices undergoing specific clinical trials.
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NOV 13
02...00023??
963214
PREMARKET NOTIFICATION Cordis Corporation ST Steerable Guidewire
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Common or Usual Name: Catheter Guide Wire
Proprietary Name: Cordis ST Steerable Guidewire
Name of Predicate Devices II.
Cordis WIZDOM Steerable Guidewire (K953760) ACS HI-TORQUE FLOPPY/FLOPPY II/Intermediate/Standard Guide Wire (K881897)
III. Classification
Catheter Guide Wire, Class II - 21 CFR 870.1330 74DQX - Cardiovascular Devices
IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Cordis ST Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The Cordis ST Steerable Guidewire incorporates a stainless steel corewire and radiopaque coil. The shaft is coated with PTFE.
VI. Biocompatibility
All materials have been tested as specified by the FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1). All material demonstrated compatibility with biological tissue by meeting the acceptance requirements stipulated in the test protocols.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.