Who is the manufacturer of SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT?

Tayside Flow Technologies Limited filed the 510(k) submission for SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT (K094044).

What is the FDA product code for SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT?

DSY. It is classified under 21 CFR 870.3450 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT

Q: What are the predicate devices for SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT?

Veryan Medical SwirlGraft™ Graft (K051312/K060741); Bard IMPRA Venaflo® Vascular Access Graft (K052282); Bard IMPRA CenterFlex® Vascular Access Graft (K924360); Vascutek PTFE Supported ePTFE Vascular Prostheses (K043552).

K094044 · Tayside Flow Technologies Limited · DSY · Mar 23, 2010 · Cardiovascular

Device Facts

Record ID	K094044
Device Name	SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
Applicant	Tayside Flow Technologies Limited
Product Code	DSY · Cardiovascular
Decision Date	Mar 23, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3450
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Spiral Laminar Flow™ Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis. ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.

Device Story

Device is a vascular prosthesis for hemodialysis access; consists of straight ePTFE tubular graft with external spiral flow inducer and inducer indicator made of ChronoFlex C-80A polyurethane. Inducer segment propagates spiral laminar flow into distal circulation to improve hemodynamics; indicator ring marks proximal end of inducer to prevent cannulation in that segment. Used in hospital operating theatres by surgeons; implanted subcutaneously. Benefits include improved flow characteristics compared to standard straight grafts. Device does not use active sensors or software; flow induction is purely mechanical based on graft geometry.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (ISO 7198 physical testing, water permeability, tensile strength, suture retention, dynamic compliance), computational fluid dynamics (CFD), flow rig analysis, and animal studies (mini-pigs, sheep, dogs) evaluating safety, blood flow models, and performance of the spiral flow design.

Technological Characteristics

Straight tubular ePTFE vascular graft with external spiral flow inducer and indicator ring. Inducer/indicator material: ChronoFlex C-80A (biodurable medical grade polyurethane). Diameters: 5, 6, 7mm. Mechanical flow induction principle. Sterilization method not specified. No software or active energy source.

Indications for Use

Indicated for patients requiring subcutaneous arteriovenous conduit for hemodialysis vascular access. Implantation must be performed by trained physicians/surgeons in a hospital operating theatre.

Regulatory Classification

Identification

A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”

Predicate Devices

Veryan Medical SwirlGraft™ Graft (K051312/K060741)
Bard IMPRA Venaflo® Vascular Access Graft (K052282)
Bard IMPRA CenterFlex® Vascular Access Graft (K924360)
Vascutek PTFE Supported ePTFE Vascular Prostheses (K043552)

Reference Devices

TFT SLF™ Vascular Peripheral Graft (K083169)

Related Devices

K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) · Vascular Flow Technologies Limited · Oct 20, 2025
K142062 — SPIRAL FLOW PERIPHERAL VASCULAR GRAFT · Vascular Flow Technologies, Ltd. · Nov 20, 2014
K083169 — EPTFE SLFTM SPIRAL VASCULAR GRAFT · Tayside Flow Technologies Limited · Mar 30, 2009
K150389 — Spiral Flow Peripheral Vascular Graft · Vascular Flow Technologies, Ltd. · May 6, 2015
K971192 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT · Impra, Inc. · Apr 15, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ K०५५०५५ MAR 2 3 2010 . i ## Tayside Flow Technologies Ltd. Traditional 510(k) For the Spiral Laminar Flow™ Vascular Anteriovenous Graft 510(k) Summary This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92. Submitter's Name: Tayside Flow Technologies Limited Submitter's Address: Tayside Flow Technologies Ltd: Unit 22, Prospect Business Centre Technology Park, Dundee Scotland, DD2 1TY +44 (0) 1382 598 532 Telephone Fax +44 (0) 1382 598 528 Establishment Registration Number: 3007676031 Contact Person: Edwin Lindsay Telephone +44 (0) 7917134922 Date Prepared: 18" March 2010 {1}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary ### Device Classification Information: | Regulation Number | Device Name | Device Class | Product Code | Classification Panel | |----------------------|---------------------------------------------------------------|-----------------|-----------------|-------------------------| | 870.3450 | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | Class 2 | DSY | Cardiovascular | | 870.3450 | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | Class 2 | DYF | Cardiovascular | ### Device Trade Name: Spiral Laminar Flow™ Vascular Arteriovenous Graft ### Device Common Name: ePTFE Vascular Graft with SLF™ ### Intended Use: The Spiral Laminar Flow™ Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis. ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation. ### Summary of Substantial Equivalence: The Tayside Flow Technologies (TFT) Spiral Laminar Flow™ Vascular Arteriovenous Graft is ട്രവിവിച്ചിരിക്കുന്നു. അവലംബം Limited SwitlGraft™ Graft (K051312/K060741), Bard IMPRA Venaflo® Vascular Access Graft (K052282), Bard IMPRA CenterFlex® Vascular Access Graft (K924360) and Vascutek PTFE Supported ePTFE Vascular Prostheses (K043552). ### Device Description: The TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is to be used as an arteriovenous conduit for hemodialysis access. The graft has a specially designed section which is intended to induce spiral laminar flow. This section is designed to propagate spiral flow though the graft and into the distal circulation. TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is manufactured from a straight tubular expanded polytetrafluoroethylene (ePTFE) vascular graft. The straight graft is combined with TFT's unique SLF™ external spiral flow inducer and inducer indicator, both made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane. The inducer indicator is a palpable ring over the proximal end of the spiral flow inducer. Its purpose is to indicate to the user where the spiral inducer segment begins since it is intended that cannulation in this segment should be avoided. {2}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Arteriovenous Graft Technological Characteristics: A comparative review of the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft with the predicate devices found that the technological characteristics, performance and principle of operation were substantially equivalent. A comparison is presented in the table below: | Property | New Device: TFT SLF™ Vascular Arteriovenous Graft | TFT SLF™ Vascular Peripheral Graft | Veryan Medical SwirlGraft™ Vascular Access Graft | Bard Venaflo Vascular Access Graft | Bard IMPRA CenterFlex Vascular Access Graft | Vascutek Arteriovenous Graft | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------| | Device Manufacturer | Tayside Flow Technologies Ltd | Tayside Flow Technologies Ltd | Veryan Medical Ltd. | Bard IMPRA | Bard IMPRA | Vascutek Ltd. | | Device Trade Name | Spiral Laminar Flow™ Vascular Arteriovenous Graft | Spiral Laminar Flow™ Vascular Peripheral Graft | SwirlGraft™ Vascular Access Graft | Venaflo™ II Vascular Graft | IMPRA CenterFlex Grafts | Maxiflo With PTFE Support Seal PTFE with PTFE Support | | 510(K) Number | N/A | K083169 | K051312/ K060741 | K052282 | K924360 | K043552 | | Device Common Name | ePTFE Vascular Graft with SLF™ | ePTFE Vascular Graft with SLF™ | ePTFE Vascular Graft | ePTFE Vascular Graft Prosthesis | ePTFE Vascular Graft Prosthesis | ePTFE Vascular Graft Prosthesis | | Device Classification name | Prosthesis, Vascular Graft, Of 6mm and Greater Diameter and Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | Prosthesis, Vascular Graft, Of 6mm and Greater Diameter and Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | Prosthesis, Vascular Graft, Of 6mm and Greater Diameter | Prosthesis, Vascular Graft, Of 6mm and Greater Diameter | Prosthesis, Vascular Graft, Of 6mm and Greater Diameter | Prosthesis, Vascular Graft, Of 6mm and Greater Diameter | | Device Classification | Class II | Class II | Class II | Class II | Class II | Class II | | Materials | ePTFE and PU | ePTFE, PTFE and PU | ePTFE | ePTFE and PTFE | ePTFE and PTFE | ePTFE and PTFE | | Tube | External spiral inducer 6cm long at the distal end of tube | External spiral inducer 10cm long at the distal end of tube | Small amplitude helical geometry along the tube length | Straight tube distal end diameter radially expanded | Straight tube | Straight tube | | Beading | No | Yes | No | Partial beading optional | Partial beading optional | Yes | | Distal End Modification | Yes | Yes | No | Yes | No | No | | Diameter | 5, 6 and 7mm | 5, 6, 7 and 8mm | 6mm | 6, 7 and 8mm | 6, 7 and 8mm | 6, 7 8 and 10 mm | | Intended Use | Subcutaneous arteriovenous | Bypass or reconstruction | Subcutaneous | Subcutaneous | Subcutaneous | Creation of subcutaneous | {3}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Anteriovenous Graft 510(k) Summary | Property | New Device: TFT SLFTM Vascular Arteriovenous Graft | TFT SLFTM Vascular Peripheral Graft | Veryan Medical SwirlGraftTM Vascular Access Graft | Bard Venaflo Vascular Access Graft | Bard IMPRA CenterFlex Vascular Access Graft | Vascutek Arteriovenous Graft | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | | conduits for hemodialysis access | of occluded or diseased peripheral arterial blood vessels. | conduit for vascular access. | conduits for blood access only | conduits for blood access only | arteriovenous conduits for blood access, bypass or reconstruction of occluded or diseased arterial blood vessels | | Intended Location of Use | Forearm, upper arm, thigh | Either above or below the knee | Forearm, upper arm, thigh | Forearm, upper arm. thigh | Forearm, upper arm, thigh | Forearm, upper arm, thigh, below knee | | Device Description | An ePTFE graft with a pre-trimmed cuff and unique SLFTM external spiral flow inducer and inducer indicator made from Medical Grade polyurethane (PU) at the distal end . | An ePTFE supported graft with a pre- trimmed cuff and and unique SLFTM external spiral made from Medical Grade polyurethane (PU) at the distal end. | A 6mm expanded ePTFE vascular graft that is manufactured with a small amplitude helical geometry along its entire length. The Swirl Graft Vascular Access Graft is a standard wall ePTFE construction with no external support. | An expanded ePTFE vascular graft with a radially expanded pre- formed venous cuff at the distal end. The grafts are available in various lengths and diameters, in straight, stepped and tapered configurations, with and without external support and with or without a carbon lining | An expanded ePTFE vascular graft The grafts are available in various lengths and diameters, in straight, tapered and stepped configurations, with and without external support and with or without a carbon lining | A supported or unsupported ePTFE vascular graft | ### Performance Data: Bench testing and animal data demonstrated that the safety and effectiveness of the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is equivalent to the predicate devices. - . Biocompatibility Testing Tayside Flow Technologies (TFT) Spiral Laminar Flow™ Vascular Arteriovenous Graft is a straight tubular vascular graft made from expanded polytetrafluoroethylene (ePTFE). The unique SLF™ spiral flow inducer and inducer indicator are injection molded onto the outer surface of the straight graft. The inducer and indicator are made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane, further information is available in as section 11. To determine the biocompatibility testing required for the TFT graft materials the following was taken into account: {4}------------------------------------------------ ### For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary - The requirements of ISO 10993 Part1 and especially Annex A of this part which . provides guidance on the selection of tests - The fact that the materials used in the TFT graft are already well-characterised and . are approved for use as long-term vascular implants. Section 11 includes a list of vascular devices which make use of these materials and which are 510(k) cleared. Based on this analysis it was determined that the tests specified in the following parts of ISO 10993 were appropriate: parts 4, 5, 6, 10, 11 and 13. These tests performed in compliance with GLP, confirmed that the biocompatibility of the Spiral Laminar Flow™ Vascular Arteriovenous Graft is sufficient for their intended use. These test results are further supported by the fact that these materials have been in clinical use in implant applications for many years with good results. Further proof of the biocompatibility of the materials used in the TFT graft was provided by the fact that both the materials used have been cleared by FDA for vascular graft use as already mentioned. The details of the 510(k)s are given in section 11. #### Performance Testing . The determination of the optimum configuration for the TFT graft was based on 1) a literature review, 2) computational fluid dynamics (CFD) and 3) flow rig work. A number of design areas were evaluated: - 1. Clinical Literature Review (Appendix B) - 2. Helical angle (computational fluid dynamics and flow rig) - 3. Number of ridges (computational fluid dynamics and flow rig) - Height of ridge (computational fluid dynamics and flow rig) ধ - Ridge profile (computational fluid dynamics and flow rig) u - Graft profile in polyester (flow rig) 6. Good correlation of CFD data, flow rig data and in vivo data confirmed the suitability of the design. ### Haemodynamic Testing: Effect of Diameter As 6mm and 8mm grafts are commercially available for infrainguinal bypass, there is no 'industry standard' as far as diameter is concerned. However, 6mm through 8mm grafts are commonly used for arteriovenous access. To verify that 6mm and 8mm grafts have comparable blood flow characteristics, in-house flow rig and computational fluid dynamic work has been carried out. ### Physical Testing Characterisation and Physical testing has been carried out to ISO7198 Cardiovascular implants - tubular vascular prosthesis. This includes :- - . Water permeability - Circumferential tensile strength {5}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary - Longitudinal tensile strength . - Probe burst strength . - Usable length of formed material . - Relaxed internal diameter . - . Wall thickness - . Pressurised internal diameter - . Suture retention strength - . Kink diameter / radius - . Dynamic compliance The test results demonstrate that the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft has sufficient strength and physical properties to perform as intended under the expected in vivo loading conditions. ### Animal Testing ### Development of SLF grafts TFT has completed the following animal studies during the development of the TFT Spiral Laminar Flow™ ePTFE Vascular Grafts. | STUDY | Length of Recovery Study | Species Used | Description | Number In Each Group | Purpose | |----------------------------------------|--------------------------------|--------------|----------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------| | HSAW (100) | 6 Months | Mini-Pig | Bard Control vs. Bard+TFT Spiral POLYESTER 8 mm | 8 | | | HSAW (103) | 1 Week | Mini-Pig | Bard Control vs. Bard+TFT Spiral POLYESTER 8 mm | 1 | | | HSAW (104) | 1 Months | Mini-Pig | Bard Control vs. Bard+TFT Spiral vs. TFT (McMurry) POLYESTER 8 mm | 2 | Blood flow Model Development | | NPIMR (pilot) | 1 Month | Sheep | TFT (McMurry) POLYESTER 8 mm | 1 | | | NPIMR (SH- 02) | 3 Month | Sheep | Bard Control vs. Bard+TFT Spiral POLYESTER 8 mm Model Development | 5 | | | CHUM (TFT- CHUM pilot) TFT-8-004 | 2 Weeks | Dog | Bard Control vs. TFT (McMurry) POLYESTER 8 mm | 2 | Blood flow Model Development AND Safety | | CHUM (TFT- 8-005) | 6 Weeks | Dog | Bard Control vs. TFT (McMurry) POLYESTER 8 mm | 2 | Study Development | | CHUM and MHI (TFT-8-006) | 20 Weeks | Dog | Bard Control vs. TFT (McMurry) POLYESTER 8 mm | 10 | Safety Study/ Proof of principle and Performance | | TFT-8-007 | 14 Weeks | Sheep | BARD ePTFE 8mm | 2 | Proof of principle study | {6}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary | STUDY | Length of Recovery Study | Species Used | Description | Number In Each Group | Purpose | |-----------------|-----------------------------|--------------|---------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------| | NPIMR (SH03) | 2 Weeks | Sheep | 4 mm Polyester Spiral Grafts | 4 | Proof of principle study (Performance Study 4 mm Vascular Grafts) | | G0003-09 | 2 Weeks | Pig | 6mm ePTFE Spiral Access Grafts v 6mm ePTFE Control Access Grafts | 2 | Proof of principle study (Performance Study 6 mm Vascular Grafts) | ### Safety and Effectiveness: The TFT SLF™ Vascular Arteriovenous Graft utilises similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate devices, the TFT SLFTM Vascular Arteriovenous Graft indicated no adverse indications or results. It is our determination that the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device. {7}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 Tayside Flow Technologies LTD c/o Mr. Rudy Mounia 1141 E. Hawken Way Chandler, AZ 85286 ## MAR 2 3 2010 Re: K094044 Trade Name: Spiral Laminar Flow™M Vascular Arteriovenous Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: II (two) Product Code: DSY Dated: December 28, 2009 Received: December 31, 2009 Dear Mr. Mounia: .. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {8}------------------------------------------------ Page 2 - Mr. Rudy Mounia Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (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 (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/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Dma R. Vi. Amer Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # Tayside Flow Technologies Ltd. Traditional 510(k) For the Spiral Laminar Flow™ Vascular Arteriovenous Graft ### Indications for Use 510(k) Number (if known): 《0 9 40 4-4 Device Name: Spiral Laminar Flow™ Vascular Arteriovenous Graft Indications for Use: The Spiral Laminar Flow™ Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis. ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation, Prescription Use × (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ~~~~~~~~~ R ~~~~~~~~ (Division Sign-Off) Division of Cardiovascular Devices Page 1 of 1 510(k) Number_ko94044

SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

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SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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