Usci Super 9 Ptca Guiding Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K922541 FDA 510(k)
- FDA Product Code
- DQI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1800 FDA 510(k)
- Regulation Number
- 870.1800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a PTCA guiding catheter, classified as a withdrawal/infusion pump under regulation 870.1800, with product code DQI and medical specialty in cardiovascular. It is a sterile, single-use device designed for guiding interventional tools during percutaneous transluminal coronary angioplasty procedures.
Supplied in a sterile condition for single-use only, the device is intended for use in cardiovascular clinical settings. It has received FDA 510(k) clearance under K922541, with a traditional clearance type and decision date of December 8, 1992, and is classified as a Class II medical device.
Frequently asked questions
What is the USCI SUPER 9 PTCA Guiding Catheter used for?
It is designed to guide interventional tools during percutaneous transluminal coronary angioplasty procedures in cardiovascular clinical settings, enabling precise delivery of devices to coronary arteries.
Is the USCI SUPER 9 PTCA Guiding Catheter sterile and single-use?
Yes, the device is supplied in a sterile condition and is intended for single-use only, as stated in its description, to prevent cross-contamination and ensure patient safety during procedures.
What regulatory clearance does the USCI SUPER 9 PTCA Guiding Catheter have?
It received FDA 510(k) clearance under submission K922541 on December 8, 1992, with a traditional clearance type and was found substantially equivalent to a predicate device.
What is the device classification and product code for the USCI SUPER 9 PTCA Guiding Catheter?
It is classified as a Class II medical device under regulation 870.1800 with product code DQI, falling under the withdrawal/infusion pump category in the cardiovascular specialty.
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 SUPER 9 PTCA GUIDING CATHETER (K922541) - FDA 510 (k), USCI SUPER 9 PTCA GUIDING CATHETER - Innolitics, PDF K922541 - Usci Super 9 Ptca Guiding Catheter, Usci Super 9 Ptca Guiding Catheter 510(k) K922541 - 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 | K922541 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K922541 24 fields · synced Sep 22, 2026