RELIANT STENT GRAFT BALLOON CATHETER

K050038 · Medtronic Endovascular Innovations · DQY · Apr 13, 2005 · Cardiovascular

Device Facts

• Record ID: K050038
• Device Name: RELIANT STENT GRAFT BALLOON CATHETER
• Applicant: Medtronic Endovascular Innovations
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reliant Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Device Story

The Reliant Stent Graft Balloon Catheter is a percutaneous catheter used for temporary vessel occlusion or vascular prosthesis expansion. It is operated by a physician in a clinical setting. The device functions as a balloon catheter; it is inserted into the vasculature to the target site, where the balloon is inflated to either block blood flow or exert radial force to expand a stent graft. The output is the mechanical action of the balloon. This assists in endovascular procedures, potentially benefiting patients by facilitating stent graft placement or managing vessel flow.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous balloon catheter; Class II; Product Code DQY. Design features include catheter shaft and inflatable balloon for vessel occlusion or prosthesis expansion. Sterilization and specific material standards are not detailed in the provided text.

Indications for Use

Indicated for temporary occlusion of large vessels or expansion of vascular prostheses in patients requiring such procedures.

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

• CODA Balloon Catheter (K032869)
• Iliac Balloon Catheter (K003495)
• Large Diameter Occlusion Balloon Catheter (K002286)

Submission Summary (Full Text)

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K050038

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510(k) Pre-Market Notification Reliant Stent Graft Balloon Catheter Medtronic, Inc.

## 510(k) Summary

| Submitter: | Medtronic Vascular<br>3576 Unocal Place<br>Santa Rosa, CA 95403<br>USA |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Willie Mitchell<br>Associate Regulatory Affairs Specialist<br>[phone]<br>[phone] - FAX<br>[e-mail] |
| Date Prepared: | January 6, 2005 |
| Trade Name: | Reliant Stent Graft Balloon Catheter |
| Common Name: | Balloon Catheter |
| Classification Name: | Percutaneous Catheter |
| Predicate Devices: | The CODA Balloon Catheter (K032869) manufactured by<br>Cook Incorporated (vessel occlusion and expansion of<br>vascular prosthesis, product code DQY), and was cleared by<br>FDA on November 19, 2003.<br><br>The Iliac Balloon Catheter (K003495) manufactured by<br>Guidant Corporation (prosthesis expansion, product code<br>DQY), and was cleared by FDA on February 7, 2001.<br><br>The Large Diameter Occlusion Balloon Catheter (K002286)<br>manufactured by Cook Incorporated (vessel occlusion,<br>product code MJN), and was cleared by FDA on March 22,<br>2001. |
| Substantial Equivalence: | The Reliant Stent Graft Balloon Catheter is substantially<br>equivalent to the predicate devices listed above, as it is<br>comparable with respect to their intended use, overall catheter<br>configuration, and performance characteristics. |

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

APR 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Vascular c/o Mr. Willie Mitchell Associate Regulatory Affairs Specialist 3576 Unocal Place Santa Rosa, CA 95403

Re: K050038

Reliant Stent Graft Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: January 6, 2005 Received: January 7, 2005

Dear Mr. Mitchell:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 3 ro(x) premainted in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interests for use stated in the enclosure) the aventified the aveces marketed in interstate for use stated in the cherosule) to regard manating to the Medical Device American be have a Frank Frank Drus commerce prior to May 20, 1970, the enational with the provisions of the Federal Food. Drug. devices mat have been reclassified in accerative mail as premarket approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a premarket approval a and Cosmelle Act (Act) that do not require appear al controls provisions of the Act. The You may, therefore, market the device, salyer to the genirements for annual registration, listing of the and general controls provisions of the Fieldes some in the measures misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) this. Existing major regulations affecting your device can may be subject to such additional controller Lifting of July 2011 - 11 addition, FDA may be found in the Oode of Proderal Loncerning your device in the Federal Register.

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## Page 2 - Mr. Willie Mitchell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backers complies with other requirements of the Act
that FDA has made a determination that your device complies with other require that FDA has made a decermination that Jour as research agencies. You must or any Federal statures and regulations daminities, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercess, cannotacturing practice requirements as set CFR Part 607), labeling (21 CFR Part 820); go d if applicable, the electronic forin in the quality systems (QD) regalizations (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons 551 - 15 cm can bescribed in your Section 5 10(k)
This letter will allow you to begin marketing your device to logics to Jogal I his letter will anow you to oegin manxellig of substantial equivalence of your device to a legally premarket notification. THC PDA miding of backandal of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your de vice of other note the regulation entitled, the regulation entitled, the move abtain contact the Office of Complanee at (210) 276 of 807.97). You may obtain "Misbranding by reference to premainer noutheast in the Act from the Division of Small
on (800) of everal information on your responsibilities under the Act from the 1900 638 other getteral information on your responsible in toll-free number [phone] or
Manufacturers, International and Consumer Assistance of Archives (demansion) by w Manufacturers, International and Octoberhers http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duma R. Vaitiner

Image /page/2/Picture/5 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. The signature is black and is on a white background. The signature is small and compact.

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): not yet assigned KO5CC 3 E

Device Name: Reliant Stent Graft Balloon Catheter

Indications For Use:

The Reliant Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

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)

Dams R. Vacher

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_K650038