(96 days)
The Reliant Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Not Found
The provided text is a 510(k) summary for the Reliant Stent Graft Balloon Catheter. It outlines the device's intended use, classification, and predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
This document primarily serves to demonstrate substantial equivalence to previously cleared devices based on intended use, overall catheter configuration, and performance characteristics (which are assumed to be similar to the predicates but not detailed in this summary).
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about related studies based only on the provided text. This information would typically be found in more comprehensive testing summaries or clinical trial reports submitted as part of the 510(k) application, but it is not present in this specific summary document.
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510(k) Pre-Market Notification Reliant Stent Graft Balloon Catheter Medtronic, Inc.
510(k) Summary
| Submitter: | Medtronic Vascular3576 Unocal PlaceSanta Rosa, CA 95403USA |
|---|---|
| Contact Person: | Willie MitchellAssociate Regulatory Affairs Specialist(707) 591-2091(707) 566-1432 - FAXwillie.mitchell@medtronic.com |
| 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 byCook Incorporated (vessel occlusion and expansion ofvascular prosthesis, product code DQY), and was cleared byFDA on November 19, 2003.The Iliac Balloon Catheter (K003495) manufactured byGuidant Corporation (prosthesis expansion, product codeDQY), and was cleared by FDA on February 7, 2001.The Large Diameter Occlusion Balloon Catheter (K002286)manufactured by Cook Incorporated (vessel occlusion,product code MJN), and was cleared by FDA on March 22,2001. |
| Substantial Equivalence: | The Reliant Stent Graft Balloon Catheter is substantiallyequivalent to the predicate devices listed above, as it iscomparable with respect to their intended use, overall catheterconfiguration, 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 (800) 638-2041 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
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).