Who is the manufacturer of BardPort®, SlimPort®, and X-Port® Implanted Ports?

C.R. Bard, Inc. filed the 510(k) submission for BardPort®, SlimPort®, and X-Port® Implanted Ports (K153359).

What is the FDA product code for BardPort®, SlimPort®, and X-Port® Implanted Ports?

LJT. It is classified under 21 CFR 880.5965 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for BardPort®, SlimPort®, and X-Port® Implanted Ports?

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

What are the predicate devices for BardPort®, SlimPort®, and X-Port® Implanted Ports?

X-Port® Implanted Ports (K022983); BardPort® and SlimPort® Implanted Ports (K924250); BardPort® Implanted Ports (K880571); Hickman Plastic Subcutaneous Port (K873213); Hickman Titanium Subcutaneous Port (K870260).

Who can help prepare an FDA 510(k) submission like BardPort®, SlimPort®, and X-Port® Implanted Ports?

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.

BardPort®, SlimPort®, and X-Port® Implanted Ports

K153359 · C.R. Bard, Inc. · LJT · May 20, 2016 · General Hospital

Device Facts

Record ID	K153359
Device Name	BardPort®, SlimPort®, and X-Port® Implanted Ports
Applicant	C.R. Bard, Inc.
Product Code	LJT · General Hospital
Decision Date	May 20, 2016
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.5965
Device Class	Class 2
Attributes	Therapeutic

Intended Use

BardPort®, SlimPort®, and X-Port® Implanted Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system.

Device Story

Implanted vascular access device; consists of rigid housing and self-sealing septum with attached catheter. Used for long-term, repeated vascular access; enables infusion of medications, fluids, nutrition, blood products, and blood withdrawal. Physician implants port subcutaneously; tunnels catheter into blood vessel (typically superior vena cava). Healthcare providers access port via non-coring needle through skin. Eliminates need for repeated venipuncture. Benefits patient by providing reliable, long-term access for chronic therapies.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included stem-catheter connection leak, tensile, and burst tests; Groshong® catheter valve crack pressure; catheter body tensile strength, stiffness, elongation, burst pressure, collapse, priming volume, tip tensile strength, tunneler connection, radiopacity, and fluid/air leak tests. Testing demonstrated performance equivalent to predicates.

Technological Characteristics

Implanted infusion port and catheter. Materials: Silicone (catheter), Polycarbonate (catheter lock), Delrin/Titanium (port body). Dimensions modified from predicates. Connectivity: None. Sterilization: Ethylene Oxide (AAMI/ANSI/ISO 11135-1). Standards: ISO 10555-1/3, ISO 10993-1/7, AAMI/ANSI ST72, ASTM F2503-13.

Indications for Use

Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

X-Port® Implanted Ports (K022983)
BardPort® and SlimPort® Implanted Ports (K924250)
BardPort® Implanted Ports (K880571)
Hickman Plastic Subcutaneous Port (K873213)
Hickman Titanium Subcutaneous Port (K870260)

Reference Devices

PowerPort® Implanted Ports with Groshong® Catheter (K081311)

Related Devices

K032044 — X-PROT DUO PORT · C.R. Bard, Inc. · Jul 10, 2003
K034065 — MODIFICATION TO X-PORT DUO PORT · C.R. Bard, Inc. · Jan 15, 2004
K251253 — PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port · Bard Access Systems, Inc. · Jun 18, 2025
K080645 — STD MED PRIMO PORT POLY · Std Med, Inc. · May 2, 2008
K964538 — R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM · Boston Scientific Corp · Mar 10, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized representation of three human profiles facing to the right, with flowing lines beneath them that could represent water or fabric. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 20, 2016 C.R. Bard, Inc. Mr. James Davis Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116 Re: K153359 Trade/Device Name: BardPort®, SlimPort®, and X-Port® Implanted Ports Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: April 21, 2016 Received: April 22, 2016 Dear Mr. Davis: 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. {1}------------------------------------------------ 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 of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, Tina Kiang -s for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K153359 Device Name: BardPort®, SlimPort®, and X-Port® Implanted Ports Indications for Use: The BardPort®, SlimPort®, and X-Port® implanted ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Prescription Use (Part 21 CFR 801 Subpart D) (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) {3}------------------------------------------------ ## 510(k) Summary 21 CFR 807.92 ## BardPort , SlimPort , and X-Port Implanted Ports | General Provisions | Submitter Name: Address: | Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Contact Person | James R. Davis Regulatory Affairs Specialist James.R.Davis@crbard.com T: 801.522.5456 F: 801.522.5425 | | | Date of Preparation: | February 5th, 2016 | | Subject Device | Trade Name: Common/Usual Name: Classification Name: Product Code: Regulation: | BardPort®, SlimPort®, and X-Port® Implanted Ports Implanted Infusion Port & Catheter Subcutaneous, Implanted, Intravascular Infusion Port and Catheter LJT 21 CFR 880.5965 | | Predicate Devices | Current Trade Name: Classification Name: Premarket Notification: Manufacturer: | X-Port® Implanted Ports Subcutaneous, Implanted, Intravascular Infusion Port and Catheter K022983: BardPort® X-Port® isp Port Bard Access Systems, Inc. | | | Current Trade Name: Classification Name: Premarket Notification: Manufacturer: | BardPort® and SlimPort® Implanted Ports Subcutaneous, Implanted, Intravascular Infusion Port and Catheter K924250: Plastic Low Profile Subcutaneous Port Bard Access Systems, Inc. | | | Current Trade Name: Classification Name: Premarket Notification: Manufacturer: | BardPort® Implanted Ports Subcutaneous, Implanted, Intravascular Infusion Port and Catheter K880571: Cath-Tech Port Implantable Vascular Access System Bard Access Systems, Inc. | | Predicate Devices (continued) | Current Trade Name: | BardPort® Implanted Ports | | | Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port and Catheter | | | Premarket Notification: Manufacturer: | K873213: Hickman Plastic Subcutaneous Port Bard Access Systems, Inc. | | | Current Trade Name: | BardPort® Implanted Ports | | | Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port and Catheter | | | Premarket Notification: Manufacturer: | K870260: Hickman Titanium Subcutaneous Port Bard Access Systems, Inc. | | Bundled 510(k) Submission Justification | Multiple Predicate Devices are provided because a Bundled 510(k) Submission is appropriate for the subject devices since the scientific and regulatory issues are most efficiently addressed during one review. The same changes are being performed to all of the Predicate Device baselines. Additionally, following the criteria given within the Bundled 510(k) FDA Guidance: the performance data is the same for the subject devices, the General Hospital review branch is the only branch involved with the review process and all of the Predicate Devices have the same indications for use. | | | Reference Device | Current Trade Name: Classification Name: | PowerPort® Implanted Ports with Groshong® Catheter Subcutaneous, Implanted, Intravascular Infusion Port and Catheter | | | Premarket Notification: Manufacturer: | K081311: PowerPort® Implanted Ports with Groshong® Catheter Bard Access Systems, Inc. | | Reference Devices Justification | The references device is provided because the exact same changes in dimensions to the Port-Catheter Stem and Catheter Lock as well as the exact same Groshong® Catheter formulation change and Catheter Lock radiopaque material were cleared within the K081311 clearance. These exact same design features cleared in K081311 are being adapted to the BardPort®, SlimPort®, and X-Port® Implanted Ports. | | | Device Description | BardPort®, SlimPort®, and X-Port® Implanted Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. BardPort®, SlimPort®, and X- Port® Implanted Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation. BardPort®, SlimPort®, and X-Port® Implanted Ports can be used for routine vascular access using a non-coring access needle. | | | Intended Use | BardPort®, SlimPort®, and X-Port® Implanted Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system. | | | Indications for Use | The BardPort®, SlimPort®, and X-Port® Implantable Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. | | | Technological Characteristics | Technological characteristics of the subject BardPort®, SlimPort®, and X-Port® Implantable Ports are substantially equivalent with respect to basic design and function to those of the predicate devices. The Port-Catheter Stem and Catheter Lock design changes have different dimensions in comparison to the predicate device. Additionally, the Groshong® Catheter formulation is different from the predicate device to make a solid blue extrusion and the Catheter Lock radiopaque material is different so that the radiopaque band can be printed onto the subject Catheter Lock. The differences are not critical to the intended use of the device. | | {4}------------------------------------------------ {5}------------------------------------------------ | Subject and Predicate Device Comparison (K022983) | | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | SUBJECT DEVICE | PREDICATE DEVICE | | | X-Port® Implanted Ports | BardPort® X-Port® isp Port | | Note | Bold red font: Difference between the subject device and the current regulatory baseline of the predicate device. Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | | | Owner | Same | Bard Access Systems, Inc. | | 510(k) Status | Subject of this Premarket Notification | K022983 Concurrence Date: September 25, 2002 | | Classification | Same | 21 CFR 880.5965 - Class II LJT - Subcutaneous, implanted, intravascular infusion port and catheter | | Intended Use | Same | Non Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system. | | Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. | | Duration of Use | Same | Long term (>30 days) | | Insertion Site | Same | Port is implanted subcutaneously with catheter tunneled and inserted in blood vessel | | Catheter Tip Location | Same | Central venous system - lower 1/3 of superior vena cava preferred | | Catheter Dimensions | Same | Usable Length: 45cm French Size: 8 | | Port Body Dimensions | Same | Reservoir Volume: 0.6 mL Septum Diameter: 12.7 mm | | Port-Catheter Stem Dimensions | Total Length: 0.570" | Total Length: 0.565" | | Catheter Lock Dimensions | Total Length: 0.405" Lock Step Ø: .100" | Total Length: 0.552" Lock Step Ø: 0.100" | | Catheter Material | Silicone with a solid blue extrusion | Silicone with a striped blue extrusion | | Port Body Material | Same | Port Base & Top: Delrin Suture Plug(s) & Septum: Silicone | | Port-Catheter Stem Material | Same | Titanium | | Catheter Lock Material | Polycarbonate with radiopaque print | Polycarbonate with radiopaque sleeve | {6}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ | Subject and Predicate Device Comparison (K924250) | | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | SUBJECT DEVICE BardPort® and SlimPort® Implanted Ports | PREDICATE DEVICE Plastic Low Profile Subcutaneous Port | | Note | Bold red font: Difference between the subject device and the current regulatory baseline of the predicate device. Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | | | Owner | Same | Bard Access Systems, Inc. | | 510(k) Status | Subject of this Premarket Notification | K924250 Concurrence Date: October 4, 1993 | | Classification | Same | 21 CFR 880.5965 – Class II LJT - Subcutaneous, implanted, intravascular infusion port and catheter | | Intended Use | Same | Non Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system. | | Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. | | Duration of Use | Same | Long term (>30 days) | | Insertion Site | Same | Port is implanted subcutaneously with catheter tunneled and inserted in blood vessel | | Catheter Tip Location | Same | Central venous system - lower 1/3 of superior vena cava preferred | | Catheter Dimensions | Same | Usable Length: 45cm French Size: 8 | | Port Body Dimensions | Same | Reservoir Volume: 0.3 mL Septum Diameter: 10.7 mm | | Port-Catheter Stem Dimensions | Total Length: 0.570" | Total Length: 0.565" | | Catheter Lock Dimensions | Total Length: 0.405" Lock Step Ø: .100" | Total Length: 0.552" Lock Step Ø: 0.100" | | Catheter Material | Silicone with a solid blue extrusion | Silicone with a striped blue extrusion | | Port Body Material | Same | Port Base & Top: Delrin Suture Plug(s) & Septum: Silicone | | Port-Catheter Stem Material | Same | Titanium | | Catheter Lock Material | Polycarbonate with radiopaque print | Polycarbonate with radiopaque sleeve | {7}------------------------------------------------ | Subject and Predicate Device Comparison (K880571) | | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | SUBJECT DEVICE | PREDICATE DEVICE | | | BardPort® Implanted Ports | Cath-Tech Port Implantable Vascular Access System | | Note | Bold red font: Difference between the subject device and the current regulatory baseline of the predicate device. Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | | | Owner | Same | Bard Access Systems, Inc. | | 510(k) Status | Subject of this Premarket Notification | K880571 Concurrence Date: September 18, 1991 | | Classification | Same | 21 CFR 880.5965 – Class II LJT - Subcutaneous, implanted, intravascular infusion port and catheter | | Intended Use | Same | Non Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system. | | Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. | | Duration of Use | Same | Long term (>30 days) | | Insertion Site | Same | Port is implanted subcutaneously with catheter tunneled and inserted in blood vessel | | Catheter Tip Location | Same | Central venous system - lower 1/3 of superior vena cava preferred | | Catheter Dimensions | Same | Usable Length: 45cm French Size: 8 | | Port Body Dimensions | Same | Reservoir Volume: 0.5 mL Septum Diameter: 13.0 mm | | Port-Catheter Stem Dimensions | Total Length: 0.570" | Total Length: 0.565" | | Catheter Lock Dimensions | Total Length: 0.405" Lock Step Ø: .100" | Total Length: 0.552" Lock Step Ø: 0.100" | | Catheter Material | Silicone with a solid blue extrusion | Silicone with a striped blue extrusion | | Port Body Material | Same | Port Base & Top: Titanium Suture Plug(s) & Septum: Silicone | | Port-Catheter Stem Material | Same | Titanium | | Catheter Lock Material | Polycarbonate with radiopaque print | Polycarbonate with radiopaque sleeve | {8}------------------------------------------------ | Subject and Predicate Device Comparison (K873213) | | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | SUBJECT DEVICE | PREDICATE DEVICE | | | BardPort® Implanted Ports | Hickman Plastic Subcutaneous Port | | Note | Bold red font: Difference between the subject device and the current regulatory baseline of the predicate device. Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | | | Owner | Same | Bard Access Systems, Inc. | | 510(k) Status | Subject of this Premarket Notification | K873213 Concurrence Date: October 27, 1987 | | Classification | Same | 21 CFR 880.5965 – Class II LJT – Subcutaneous, implanted, intravascular infusion port and catheter | | Intended Use | Same | Non Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system. | | Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. | | Duration of Use | Same | Long term (>30 days) | | Insertion Site | Same | Port is implanted subcutaneously with catheter tunneled and inserted in blood vessel | | Catheter Tip Location | Same | Central venous system - lower 1/3 of superior vena cava preferred | | Catheter Dimensions | Same | Usable Length: 45cm French Size: 8 | | Port Body Dimensions | Same | Reservoir Volume: 0.6 mL Septum Diameter: 12.5 mm | | Port-Catheter Stem Dimensions | Total Length: 0.570" | Total Length: 0.565" | | Catheter Lock Dimensions | Total Length: 0.405" Lock Step Ø: .100" | Total Length: 0.552" Lock Step Ø: 0.100" | | Catheter Material | Silicone with a solid blue extrusion | Silicone with a striped blue extrusion | | Port Body Material | Same | Port Base & Top: Delrin Suture Plug(s) & Septum: Silicone | | Port-Catheter Stem Material | Same | Titanium | | Catheter Lock Material | Polycarbonate with radiopaque print | Polycarbonate with radiopaque sleeve | {9}------------------------------------------------ | Subject and Predicate Device Comparison (K870260) | | | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | SUBJECT DEVICE | PREDICATE DEVICE | | | BardPort® Implanted Ports | Hickman Titanium Subcutaneous Port | | Note | Difference between the subject device and the current regulatory baseline of the predicate device. Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | | | Owner | Same | Bard Access Systems, Inc. | | 510(k) Status | Subject of this Premarket Notification | K870260 Concurrence Date: April 15, 1987…