USCI ILLUMEN-8 8F PTCA Guiding Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K910154 FDA 510(k)
- FDA Product Code
- DOY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3320 FDA 510(k)
- Regulation Number
- 862.3320 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The USCI ILLUMEN-8 8F PTCA Guiding Catheter is a Class 2 medical device classified under the Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. device name with product code DOY. It is a percutaneous transluminal coronary angioplasty (PTCA) guiding catheter designed for use in cardiovascular procedures.
The device received FDA 510(k) clearance K910154 through the Traditional pathway on April 9, 1991, and is substantially equivalent to a predicate device. It is manufactured by C.R. Bard, Inc. and is not subject to third-party review.
Frequently asked questions
What is the primary use of the USCI ILLUMEN-8 8F PTCA Guiding Catheter in cardiovascular procedures?
The USCI ILLUMEN-8 8F PTCA Guiding Catheter is specifically designed for percutaneous transluminal coronary angioplasty (PTCA) procedures. It serves as a guiding catheter to facilitate the delivery and positioning of angioplasty balloons or other interventional tools within coronary arteries during these minimally invasive treatments.
Is this catheter single-use or reusable, and what does that mean for clinical workflow?
The USCI ILLUMEN-8 8F PTCA Guiding Catheter is not explicitly described as single-use or reusable in the provided data. However, most PTCA guiding catheters are intended for single-use due to sterility and contamination risks during invasive procedures. Clinicians should follow manufacturer guidelines and institutional protocols to ensure proper use and disposal.
What are the key specifications or features that distinguish this catheter from others in its category?
The catheter is an 8 French (8F) size, which is a standard gauge for guiding catheters used in coronary interventions. The 8F size balances flexibility and torque control, making it suitable for navigating coronary arteries while providing adequate lumen space for balloon catheters or other interventional tools. The PTCA designation confirms its compatibility with angioplasty procedures.
How was the regulatory pathway for this device determined, and what does that mean for its approval status?
The device was cleared through the FDA’s Traditional 510(k) pathway on April 9, 1991, under predicate device equivalence (substantially equivalent). This means it was deemed comparable to a previously cleared device (the predicate) in terms of safety and effectiveness, allowing it to enter the market without requiring clinical trials. The Class 2 classification indicates moderate regulatory oversight, but it does not imply any restrictions on its clinical use beyond standard medical device regulations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: USCI ILLUMEN-8 8F PTCA GUIDING CATHETER - Innolitics, K910154 FDA 510 (k) - USCI ILLUMEN-8 8F PTCA GUIDING CATHETER, USCI ILLUMEN-8 8F PTCA GUIDING CATHETER 510(k) K910154 - fda.report, Usci 8f Extra Large Lumen Guide Catheter 510(k) K884502 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K910154 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K910154 24 fields · synced Sep 19, 2026