GUIDELINER CATHETER, MODELS 5571, 5572, 5573

K091750 · Vascular Solutions, Inc. · DQY · Nov 4, 2009 · Cardiovascular

Device Facts

• Record ID: K091750
• Device Name: GUIDELINER CATHETER, MODELS 5571, 5572, 5573
• Applicant: Vascular Solutions, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended 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.

Device Story

GuideLiner catheter is a percutaneous catheter used in conjunction with guide catheters to access coronary and peripheral vasculature. Device consists of a single lumen distal tube with a radiopaque marker band at the distal tip, secured to a proximal shaft. Available in three sizes for use with 6F, 7F, or 8F guide catheters. Operated by physicians in clinical settings to facilitate placement and exchange of guidewires and interventional devices. Packaged in a dispenser coil within a sterile barrier pouch; sterilized via ethylene oxide.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single lumen distal tube with radiopaque marker band; proximal shaft; available for 6F, 7F, 8F guide catheters; ethylene oxide sterilization.

Indications for Use

Indicated for use in patients requiring access to discrete regions of the coronary and/or peripheral vasculature to facilitate placement and exchange of guidewires and other interventional devices.

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

• Minnie Support Catheter (K082337)

Submission Summary (Full 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**

K091750

### Contact Person

Loucinda Bjorklund Senior Regulatory Affairs Associate Tel: [phone] (direct); Fax: [phone] Email: [e-mail]

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### 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 [phone] or [phone] 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)

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Division of Cardiovascular Devices

510(k) Numbe