(141 days)
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.
The GuideLiner is a catheter that consists of a single lumen distal tube (with a radiopaque marker band at the distal tip) secured to a proximal shaft. GuideLiner catheters are available in three sizes for use with 6F, 7F or 8F guide catheters. The catheters are packaged in a dispenser coil inside a single sterile barrier pouch and sterilized by ethylene oxide.
The provided text is a 510(k) summary for the GuideLiner catheter, a medical device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document focuses on establishing substantial equivalence to a predicate device, device description, and intended use.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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Vascular Solutions, Inc.
510(k) Summary 2
Date Prepared: June 11, 2009
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
General Information
Trade Name Common / Usual Name Classification Name Predicate Device
GuideLiner catheter Catheter 870.1250, Catheter, Percutaneous K082337, Minnie Support Catheter (Vascular Solutions, Inc.)
Device Description
The GuideLiner is a catheter that consists of a single lumen distal tube (with a radiopaque marker band at the distal tip) secured to a proximal shaft. GuideLiner catheters are available in three sizes for use with 6F, 7F or 8F guide catheters. The catheters are packaged in a dispenser coil inside a single sterile barrier pouch and sterilized by ethylene oxide.
Intended Use / Indications
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.
Substantial Equivalence and Summary of Studies
GuideLiner catheters are substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and bench testing, the result of which did not raise new safety or performance questions.
Traditional 510(k) Premarket Notification GuideLiner Catheter
NOV - 4 2009
Contact Person
Loucinda Bjorklund Senior Regulatory Affairs Associate Tel: 763.656.4208 (direct); Fax: 763.656.4253 Email: Ibjorklund@vascularsolutions.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA", which is arranged in a circular fashion around the left side of the logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. c/o Ms. Loucinda Bjorkland Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
NOV - 4 2009
K091750 Re:
Trade/Device Name: GuideLiner Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: October 8, 2009 Received: October 9, 2009
Dear Ms. Bjorkland:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becaon 310(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surver in the encreatery 77 the enactment date of the Medical Device Amendments, or to conninered province way 20, 1977, the encordance with the provisions of the Federal Food, Drug, devices marchave been require approval of a premarket approval application (PMA). and Costinetter rece that the device, subject to the general controls provisions of the Act. The r ou may, mercisions of the Act include requirements for annual registration, listing of general obtactive provision 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 If your device is classified (500 a0010) insting major regulations affecting your device can be finay be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may. round in announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i toase oc advisou that I Dr o resum that your device complies with other requirements of the Act that I Dr has made a determissions administered by other Federal agencies. You must of any I edital statutes and regulations admititions but not limited to: registration and listing (21 comply with an the Her orequirements of the Part 801); medical device reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
isma R.v. Aumer
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
KU91150 510(k) Number (if known):
Device Name: GuideLiner catheter
Indications for Use:
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Numbe
§ 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).