BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH

K050205 · Flowmedica, Inc. · KRA · Mar 4, 2005 · Cardiovascular

Device Facts

• Record ID: K050205
• Device Name: BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH
• Applicant: Flowmedica, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Mar 4, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FlowMedica Benephit™ Δ Bifurcated Infusion Catheter is intended for the infusion of fluids into the peripheral vasculature including but not limited to the renal arteries. The FlowMedica Benephit™ Δ 5Fr. Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

Device Story

System comprises Benephit™ Δ Bifurcated Infusion Catheter and 5Fr. Introducer Sheath. Catheter delivers fluids directly into peripheral vasculature, specifically targeting renal arteries. Introducer sheath provides access for interventional/diagnostic devices. Used in clinical settings by physicians; facilitates targeted infusion and vascular access. Benefits include localized delivery of therapeutic agents to peripheral vessels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bifurcated infusion catheter and 5Fr. introducer sheath. Class II device (KRA, DYB). Mechanical vascular access and infusion components.

Indications for Use

Indicated for infusion of fluids into peripheral vasculature, including renal arteries, and to facilitate entry of interventional/diagnostic devices into human vasculature.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

MAR 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FlowMedica, Inc. c/o Mr. Jeff Elkins Vice President and Chief Operating Officer 46563 Fremont Boulevard Fremont, CA 94538

Re: K050205

Trade Name: FlowMedica Bifurcated Infusion System Regulation Numbers: 21 CFR 870.1210 Regulation Names: Catheter, Continuous Flush Regulatory Class: Class II Product Codes: KRA; DYB Dated: January 28, 2005 Received: January 28, 2005

Dear Mr. Elkins:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becement the device 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 encreations) it the enactment date of the Medical Device Amendments, or to conninered prof to May 20, 1978, in eccordance with the provisions of the Federal Food, DNIg, de necs that have been recidentive in quire approval of a premarket approval application (PMA). and Cosmette Act (100) market the device, subject to the general controls provisions of the Act. The I ou may, aleretore, mailer ate as act include requirements for annual registration, listing of general controls 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 elabilities (600 as 3 10) claim major regulations affecting your device can may oc subject to back added of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Jeff Elkins

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualice of a subscription with other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a delermination that your as resear agencies. You must a or any Federal statules and regulations administered by expectively of registration and listing (21 comply with all the Act s requirements, moractice requirements as set CFK Part 807), labeling (21 CFR Part 800); good and frapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quanty systems (QD) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 product radiation control provisions (Doctoris on 2 = 2 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = I his letter will anow you to oegh manxeing of substantial equivalence of your device to a legally premarket nothcation. THC PDA miding of catonaline of .
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you cestre specific advice for your don't on one one one one the regulation entitled, comaci the Oritic of Complance at (210) = 10, 21 CFR Part 807.97). You may obtain Misoraliums by reference to premainterialities under the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number [phone] or Manufacturers, Internet and Ooksahitp://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Darrich D. Lachines

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):__K050205

## Device Name:

Benephit™ Δ Infusion System (Benephit™ Δ Bifurcated Infusion Catheter & Benephit™ Δ 5Fr. Introducer Sheath)

## Indications For Use:

The FlowMedica Benephit™ △ Bifurcated Infusion Catheter is intended for the infusion The T lowinediod Benophi. - La Dhat eeripheral vasculature including but not limited to the renal arteries.

The FlowMedica Benephit™ Δ 5Fr. Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

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)

Dumo. R. Vochner

Division Sign-Off) Orision of Cardiovascular Devices

510(k) Number ك ك و 0 د كل 50 كل

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