Who is the manufacturer of 1-4F INFINITI ANGIOGRAPHIC CATHETER?

Cordis Corp. filed the 510(k) submission for 1-4F INFINITI ANGIOGRAPHIC CATHETER (K960975).

What is the FDA product code for 1-4F INFINITI ANGIOGRAPHIC CATHETER?

DQO. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for 1-4F INFINITI ANGIOGRAPHIC CATHETER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like 1-4F INFINITI ANGIOGRAPHIC CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

1-4F INFINITI ANGIOGRAPHIC CATHETER

Q: What are the predicate devices for 1-4F INFINITI ANGIOGRAPHIC CATHETER?

Cordis Corporation 4F Nylex Angiographic Catheter (K930479); Cordis Corporation Paragon Angiographic Catheter (K921310/A).

K960975 · Cordis Corp. · DQO · Apr 2, 1996 · Cardiovascular

Device Facts

Record ID	K960975
Device Name	1-4F INFINITI ANGIOGRAPHIC CATHETER
Applicant	Cordis Corp.
Product Code	DQO · Cardiovascular
Decision Date	Apr 2, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1200
Device Class	Class 2

Intended Use

The Cordis 4F Infiniti Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system.

Device Story

Diagnostic intravascular catheter; 4F diameter; braided proximal shaft; radiopaque tip. Used by physicians in clinical settings for angiographic procedures. Device facilitates delivery of radiopaque contrast medium to specific vascular sites; enables visualization of vasculature via imaging. Benefits include precise contrast delivery for diagnostic assessment.

Clinical Evidence

Bench testing only; biocompatibility testing performed on materials.

Technological Characteristics

4F diameter; braided proximal shaft; radiopaque tip. Materials biocompatibility verified. Non-powered, passive diagnostic catheter.

Indications for Use

Indicated for patients requiring delivery of radiopaque contrast medium to selected sites in the vascular system during angiographic procedures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

Cordis Corporation 4F Nylex Angiographic Catheter (K930479)
Cordis Corporation Paragon Angiographic Catheter (K921310/A)

Related Devices

K122937 — SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) · Cook, Inc. · Dec 14, 2012
K962759 — 4F NYLEX ANGIOGRAPHIC CATHETER · Cordis Corp. · Oct 10, 1996
K233268 — Impress Angiographic Catheter · Merit Medical Systems, Inc. · May 22, 2024
K191608 — Impress Angiographic Catheter · Merit Medical Systems, Inc. · Jul 16, 2019
K102633 — BIOTEQ ANGIOGRAPHIC CATHETER · Bioteque Corp. · Sep 9, 2011

Submission Summary (Full Text)

{0} K960975 # PREMARKET NOTIFICATION 510(k) Cordis Corporation 4F Infiniti Angiographic Catheter ## SUMMARY OF SAFETY AND EFFECTIVENESS ### I. General Provisions - Common or Usual Name: Diagnostic Intravascular Catheter and Percutaneous Catheter - Proprietary Name: Cordis 4F Infiniti™ Angiographic Catheter ### II. Name of Predicate Devices - Cordis Corporation 4F Nylex Angiographic Catheter (K930479) - Cordis Corporation Paragon Angiographic Catheter (K921310/A) ### III. Classification - Class II ### 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 4F Infiniti Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system. The catheter is 4F in diameter with a braided proximal shaft and radiopaque tip. ### VI. Biocompatibility All appropriate biocompatibility tests were successfully performed on the materials used for the Cordis Corporation Infiniti Angiographic Catheters. ### VII. Summary of Substantial Equivalence The Cordis 4F Infiniti Angiographic Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available angiographic catheters. 000015