Who is the manufacturer of CORDIS OPTA5 PTA BALLOON CATHETER?

Cordis Corp. filed the 510(k) submission for CORDIS OPTA5 PTA BALLOON CATHETER (K970620).

What is the FDA product code for CORDIS OPTA5 PTA BALLOON CATHETER?

LIT. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CORDIS OPTA5 PTA BALLOON CATHETER?

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

Who can help prepare an FDA 510(k) submission like CORDIS OPTA5 PTA BALLOON 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.

CORDIS OPTA5 PTA BALLOON CATHETER

Q: What are the predicate devices for CORDIS OPTA5 PTA BALLOON CATHETER?

Cordis Opta5 PTA Balloon Catheter; Cordis Nylex Angiographic Catheter; Cordis Ducor PTA Catheter; Meditech Ultra-Thin Balloon Catheter.

K970620 · Cordis Corp. · LIT · May 6, 1997 · Cardiovascular

Device Facts

Record ID	K970620
Device Name	CORDIS OPTA5 PTA BALLOON CATHETER
Applicant	Cordis Corp.
Product Code	LIT · Cardiovascular
Decision Date	May 6, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Opta5 PTA balloon catheters is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae

Device Story

Coaxial PTA balloon catheter; distal inflatable balloon; two radiopaque marker bands for placement; balloon lumen for inflation/deflation; injectate lumen for guidewire tracking or contrast/saline injection. Used by physicians in clinical settings for percutaneous transluminal angioplasty. Device tracks over prepositioned guidewire; balloon inflated to dilate stenoses; radiopaque markers aid visualization under fluoroscopy. Benefits include restoration of blood flow in peripheral arteries and dialysis fistulae.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Coaxial catheter design; distal inflatable balloon; radiopaque marker bands; injectate lumen (max 500 psi); biocompatible materials. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring dilation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

Cordis Opta5 PTA Balloon Catheter
Cordis Nylex Angiographic Catheter
Cordis Ducor PTA Catheter
Meditech Ultra-Thin Balloon Catheter

Related Devices

K971448 — CORDIS OPTA LP PTA BALLOON CATHETER · Cordis Corp. · Jul 3, 1997
K992825 — CORDIS EXTREME PTA BALLOON CATHETER · Cordis Corp. · Sep 15, 1999
K981407 — OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER · Cordis Corp. · May 20, 1998
K971516 — CORDIS POWERFLEX PLUS PTA BALLOON CATHETER · Cordis Corp. · Jul 23, 1997
K143561 — ELM PTA Balloon Dilatation Catheter · O'Connell Regulatory Consultants, Inc. · May 19, 2015

Submission Summary (Full Text)

{0} K970620 # SUMMARY OF SAFETY EFFECTIVENESS 000034 ## I. General Provisions May 6 1997 Common or Usual Name: PTA Balloon Catheter Proprietary Name: Opta5™ PTA Balloon Catheter ## II. Name of Predicate Devices - Cordis Opta5 PTA Balloon Catheter - Cordis Nylex Angiographic Catheter - Cordis Ducor PTA Catheter - Meditech Ultra-Thin Balloon Catheter ## 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 Opta5 PTA balloon catheters is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae The Cordis Opta5 PTA balloon catheter is a coaxial design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The balloon lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub. The injectate lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 500 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon. The tip length of the long tip version is approximately 10cm and is provided with side holes. {1} 000035 # VI. Biocompatibility All materials used in the Opta5 PTA balloon catheter are biocompatible. # VII. Summary of Substantial Equivalence The Cordis Opta5 PTA balloon catheter and the referenced current Cordis Opta5 PTA balloon catheter, Cordis Ducor PTA catheter, Cordis Nylex angiographic catheter and Meditech Ultra-Thin balloon catheter are similar in their basic design, construction, indication for use and performance characteristics.