← Product Code [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY) · K112035 # VALET MICRO CATHETER (K112035) _Volcano Corporation · DQY · Jan 5, 2012 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K112035 ## Device Facts - **Applicant:** Volcano Corporation - **Product Code:** [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY.md) - **Decision Date:** Jan 5, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1250 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Valet™ Micro Catheter is indicated for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The Valet™ Micro Catheter is also indicated to infuse and deliver saline and contrast agents. The Valet™ Micro Catheter is not intended for use in the neurovasculature. ## Device Story Valet™ Micro Catheter is a support catheter consisting of a shaft and hub; available in lengths 100, 123, 135, and 150 cm; tapered outer diameters (2.3F to 1.8F or 4.0F to 3.5F); straight, 45°, or 60° angled tips. Used by physicians in clinical settings to facilitate guidewire exchange/support and deliver saline or contrast agents during peripheral and coronary vascular procedures. Device provides mechanical support for guidewires and a lumen for fluid infusion. Benefits include improved access and support during interventional procedures. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical bench testing, including dimensional verification, leak testing, bond strength, flexibility/kink testing, torque strength, radiopacity, coating integrity, particulate evaluation, burst pressure, and contrast flow rate. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous, systemic toxicity, hemolysis, complement activation, pyrogens, and in vivo thromboresistance. ## Technological Characteristics Support catheter with shaft and hub. Materials evaluated for biocompatibility per ISO/ASTM standards. Features tapered outer diameters (2.3F-1.8F, 4.0F-3.5F) and various tip angles. Mechanical performance verified via bench testing for torque, burst pressure, and flexibility. No software or electronic components. ## Regulatory 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 - Asahi Corsair Microcatheter ([K083127](/device/K083127.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 12112035 JAN - 5 2012 . # 510(K) SUMMARY of SAFETY AND EFFECTIVENESS | SPONSOR: | Volcano Corporation
2870 Kilgore Road.
Rancho Cordova, CA 95670 | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT/SUBMITTER: | Lisa M. Quaglia
Senior Director, Regulatory Affairs
Volcano Corporation
1 Fortune Drive
Billerica, MA 01821
Tel: (978) 439-3586 | | DATE OF SUBMISSION: | December 2, 2011 | | DEVICE: | Volcano Valet™ Micro Catheter | | Trade Name: | Valet™ Micro Catheter | | Common Name: | Catheter, Percutaneous | | Classification: | 21 CFR Part 870.1250
Class II Device | | PREDICATE DEVICE: | Asahi Corsair Microcatheter (K083127) | | DEVICE DESCRIPTION: | The Valet™ Micro Catheter is a support catheter
comprised of a catheter shaft and hub. It is available in
lengths 100, 123, 135, and 150 cm. The outer diameter is
available in 2 sizes and is tapered from 2.3F to 1.8F and
4.0F to 3.5F. The device offers 45° and 60° angled tips as
well as a straight tip. | | INTENDED USE: | The Valet™ Micro Catheter is indicated for use as a
conduit for the exchange/support of guidewires in the
peripheral and coronary vasculatures. The Valet™ Micro
Catheter is also indicated to infuse and deliver saline and
contrast agents. The Valet™ Micro Catheter is not
intended for use in the neurovasculature. | | COMPARISON OF
CHARACTERISTICS: | The proposed device is substantially equivalent to
currently marketed device. Both devices are support
catheters consisting of a catheter shaft and hub. The
proposed Valet™ Micro Catheter is offered in four catheter
shaft lengths whereas the predicate device is offered in
two lengths. Additionally, the Valet™ Micro Catheter offers
multiple inner lumen diameters while the predicate device
offers a single inner lumen diameter. The indications for
use is the same for both devices. | 510(k) Premarket Notification for Volcano Corporation Valet™ Micro Catheter {1}------------------------------------------------ ### PERFORMANCE DATA: Non-clinical device testing was conducted to confirm the performance of the device. Bench testing was conducted against known standards, product specification, or against the predicate device and evaluated the following: - . Dimensional Verification - Leak Testing . - Leak Testing of Air into the Hub During Aspiration . - . Catheter Bond Strength - Flexibility and Kink Test . - Torque Strength Test . - Radiopacity . - . Coating Adhesion - Coating Integrity . - Particulate Evaluation . - . Catheter Body Burst Pressure - . Contrast Media Flow Rate Biocompatibility testing was conducted on the device and the following tests were successfully completed: - Cytotoxicity . - Sensitization . - . Intracutaneous - Systemic Toxicity . - . ASTM Hemolysis - In Vitro Hemolysis . - C3a Complement Activation . - . SC5-b Complement Activation - Pyrogens . - . Hemocompatibility - In vivo Thromboresistence � Completion of these tests concluded the Valet 100 Micro Catheter is substantially equivalent to the predicate device. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JAN - 5 2012 Volcano Corporation c/o Ms. Lisa M. Quaglia Senior Director, Regulatory Affairs 1 Fortune Drive Billerica, MA 01821 Re: K112035 Trade/Device Name: Volcano Valet™ Micro Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 2, 2011 Received: December 5, 2011 #### Dear Ms. Quaglia: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) promative is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule for regally manation power and call Device Ameral Food. Drug commerce prior to May 20, 1970, the enactions and on the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) that to not require approval controls provisions of the Act. The Act. The Y ou may, therefore, market the device, basjev to weegent for annual registration, listing of the general Controls provisions of the received ing, 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 classifica (sec above) into times a considerations affecting your device can be may be subject to additional confrois: "Dalsung in Jords 800 to 898. In addition, FDA may found in the Code of I caeral resguing your device in the Federal Register. publish further announcents concerning your at novemberse determination does not mean Please be advised that FDA s issuales of a sudes with other requirements of the Act that FDA has made a determination that your device complies. You must that FDA has made a decertimation administered by other Federal agencies. You must of any Federal Statutes and regulations annumbles and limited to: registration and listing {3}------------------------------------------------ Page 2 – Ms. Lisa M. Quaglia (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. 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/CDRH/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 (240) 276-3150 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Wm. G. Killebrew رمان Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use Statement 510(k) Number (if known) Page 1 of 1 Valet™ Micro Catheter Device Name The Valet™ Micro Catheter is indicated for use as a conduit for the Indications for Use exchange/support of guidewires in the peripheral and coronary vasculatures. The Valet™ Micro Catheter is also indicated to infuse and deliver saline and contrast agents. The Valet™ Micro Catheter is not intended for use in the neurovasculature. Prescription Use X (Per 21 CFR 801.109) OR Over the Counter Use ## 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 KII 2035 510(k) Number 510(k) Premarket Notification for Volcano Corporation Valet™ Micro Catheter --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K112035](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K112035) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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