OCCLUSION BALLOON CATHETER, MODEL VENOS

K081052 · Oscor, Inc. · DYG · Jun 18, 2008 · Cardiovascular

Device Facts

• Record ID: K081052
• Device Name: OCCLUSION BALLOON CATHETER, MODEL VENOS
• Applicant: Oscor, Inc.
• Product Code: DYG · Cardiovascular
• Decision Date: Jun 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1240
• Device Class: Class 2

Intended Use

The Occlusion Balloon Catheter, model Venos™, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.

Device Story

Venos™ Occlusion Balloon Catheter is a flow-directed catheter used by physicians in clinical settings. Device functions by inflating a balloon to temporarily occlude the coronary sinus. This allows for controlled infusion of contrast media or drugs, performance of venograms, or serves as a conduit for introducing other devices into the coronary venous system. Operation is manual, performed by a clinician during cardiovascular procedures. Benefits include improved visualization of the coronary venous anatomy and targeted delivery of therapeutic or diagnostic agents.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design characteristics.

Technological Characteristics

Flow-directed catheter; balloon-tipped design for occlusion; intended for coronary sinus access. Class II device (21 CFR 870.1240).

Indications for Use

Indicated for temporary occlusion of the coronary sinus to facilitate venograms, infusion of contrast media or drugs, or the introduction of devices into the coronary venous system.

Regulatory Classification

Identification

A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2008

Oscor, Inc. Ms. Mila Doskocil Director of Regulatory Affairs/Compliance 3816 De Soto Boulevard Palm Harbor, Florida 34683

Re: K081052

Trade/Device Name: Occlusion Balloon Catheter, Model Venos™ Regulation Number: 21 CFR 870.1240 Regulation Name: Catheter, Flow-directed Regulatory Class: Class II Product Code: DYG Dated: April 10, 2008 Received: April 14, 2008

Dear Ms. Doskocil:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vo

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K081052

Device Name:

Occlusion Balloon Catheter, Model Venos™M

The Occlusion Balloon Catheter, model Venos™, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)Division of Cardiovascular Devices

K081052 510(k) Number_